Midweek update

Obesity

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Department of Health and Human Services announced Sept. 8 through the Substance Abuse and Mental Health Services Administration that it will award $383.4 million in grants to support behavioral health treatment, prevention and crisis response efforts. HHS said $252 million will support the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services. Of the remaining grants, $81.4 million will be used toward substance use treatment and prevention initiatives, and $50 million will be used to support mental health services. The Sept. 8 announcement coincided with 988 Day, which raises awareness about the 988 lifeline and the importance of mental health and suicide prevention.” 
  • Bloomber Law reports,
    • “The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.
    • “Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.
    • “Each of the agreements is bespoke, but companies generally have agreed to lower the prices they charge public programs for medicines and to launch new drugs at prices similar to those paid by other developed nations in exchange for relief from tariffs. Some companies also are offering the discounted prices directly to consumers on a Trump-branded website, though critics argue the savings are minimal for patients with insurance.”
  • Axios adds,
    • “There are troubling new signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. 
    • “Why it matters: The upward trajectory could threaten some seniors’ coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation’s debt. 
    • “Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers.
    • That was good news for enrollees who take expensive drugs for conditions like cancer, multiple sclerosis or rheumatoid arthritis and faced potentially crushing out-of-pocket costs.
    • But federal data shows demand for drugs is surging as they become more affordable, exceeding congressional scorekeepers’ spending estimates and setting off more alarms.
    • “Driving the news: Last week, congressional Medicare advisers reported that more than 1 in 5 enrollees hit Medicare Part D’s $2,000 patient cost cap in 2025 — shifting new costs to the government.”
  • Beckers Behavioral Health breaks down the Labor Department’s September 8 enforcement guidance concerning the mental health parity act into seven things to know:
    • “Certain behavioral health treatment exclusions could draw scrutiny.
    • “Prior authorization and medical necessity processes are a key enforcement area.
    • “The agency is looking closely at behavioral health networks.
    • “Compliance depends on how policies operate in practice.
    • “Telehealth, cost-sharing and visit limits can also raise compliance concerns.
    • “Plans are expected to use monitoring mechanisms to identify disparities.
    • “Corrective actions can require changes to coverage and plan operations.”
  • STAT News relates,
    • “ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 
    • “ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down.” 

From the U.S. Office of Personnel Management front,

  • My Federal Retirement tells us about “What FEHB Enrollees Should Know if They Get a Letter from Medicare This Month.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. 
    • “Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.   
    • “The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.”
  • and
    • “With a phase 3 win now fleshed out and an FDA filing recently submitted, BioMarin is advancing expansion plans for Voxzogo, looking to extend the dwarfism drug’s reach as it faces new pressure in its inaugural achondroplasia indication. 
    • “On Wednesday, BioMarin unveiled detailed results from the phase 3 CANOPY-HCH-3 trial assessing Voxzogo in children with hypochondroplasia (HCH), a milder form of achondroplasia, where the company announced a topline win back in May. 
    • “Aside from the average 2.33 cm/year improvement in annualized growth velocity (AGV) on Voxzogo that BioMarin reported out earlier this year, the company dug deeper into the magnitude of benefit its medicine could offer to children with HCH across measures like standing height and arm span after a year of treatment.
    • “BioMarin shared the data Wednesday at the European Society for Paediatric Endocrinology annual meeting and simultaneously published the results in the New England Journal of Medicine.” 
  • Cardiovascular Business points out,
    • “Luma Vision, an Irish medtech company focused on electrophysiology and interventional cardiology technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its updated Verafeye imaging and visualization platform. The company previously received FDA clearance for the artificial intelligence-powered offering in 2025; this update covers the platform’s expanded capabilities ahead of a planned commercial launch in 2027.
    • “The Verafeye platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities, helping users track imaging and ablation catheters during treatment. In addition, users are able mark locations as they go to confirm they achieve the necessary alignment.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “First responders and other New Yorkers around the World Trade Center that day have reported conditions including respiratory issues, mental health impacts and dementia. Toxins were present in the air soon after the attacks even though people were assured it was safe, according to a trove of records released this week by New York City officials.
    • “Twenty-five years later, attention is increasingly falling on cancer. 
    • “The number of 9/11 survivors who are receiving aid for cancer has roughly tripled over the last five years, according to a Washington Post analysis of reports from the World Trade Center Health Program, which funds health care for first responders and 9/11 survivors in New York. In June 2021, 8,870 survivors received aid for cancer treatment, jumping to 27,300 survivors in 2026 — numbers that sharply outpaced cancer claims among first responders.
    • “Of the roughly 54,000 survivors enrolled in the health program as of June, about half are receiving aid for cancer. Five years ago, that share was 35 percent.” * * *
    • “A recent New York University study of a smaller cohort of 9/11 survivors receiving medical aid as of 2024 reported a similar increase in cancer cases; it found that cases had increased around 2.5-fold between 2019-2024.
    • “This is something that we are worried about,” said Alan Arslan, an associate professor of population health at NYU and one of the authors of the study. “We’re seeing more and more patients.”
  • The Wall Street Journal relates,
    • “Dr. Henry Heimlich devised a new technique more than 50 years ago to stop people from choking. Simplicity, studies, shrewd promotion by its inventor—and a demonstration on The Tonight Show Starring Johnny Carson—made the Heimlich maneuver a go-to method.
    • “Now, it is fighting for the stage.
    • “Advocates, companies and some politicians argue that the Heimlich maneuver and back blows, another established method of rescuing people from choking, aren’t always enough. On social media and in state legislatures, they are plugging portable anti-choking devices, designed to suction stuck food or other objects from a person’s airway.
    • “Texas enacted a law last year requiring school districts to stock at least one such device on each campus with at least one employee trained to use it. New York City passed one, too. At least nine other states have weighed or are weighing bills to put devices into schools or other facilities.
    • “It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.” 
    • “The main U.S. maker—a company called LifeVac—has donated more than 10,000 devices to schools across the country.” * * *
    • “But medical guidelines and many researchers say there isn’t enough evidence to recommend anti-choking devices. State health departments, emergency responders and teachers unions have pushed back against proposals to require them in schools because medical guidelines haven’t endorsed them. New York City said it wouldn’t implement its law unless the devices are recommended in medical guidelines.”
  • Beckers Behavioral Health tells us,
    • “The synthetic opioid cychlorphine has been linked to at least 55 deaths nationally from 2025 to 2026, with prevalence highest in Ohio, Tennessee and Texas, MedPage Today reported Sept. 8.
    • “The Office of National Drug Control Policy said in an April drug threat notice that cychlorphine may be “up to 10 times more potent than fentanyl” and an overdose may require multiple doses of naloxone.
    • “In Tennessee, the Knox County Regional Forensic Center reported 41 overdose deaths between July 2025 and February 2026. The center tracked as many as 63 cychlorphine-associated deaths through June 30, and cychlorphine was found to be the cause in 58 of those cases.
    • “Cychlorphine has been found mainly in powders and tablets as well as counterfeit pills. Shravani Durbhakula, MD, MPH, of Vanderbilt University School of Medicine in Nashville, Tennessee, said snorting and inhaling are common, though oral exposure and injection are also possible.”
  • Cardiovascular Business informs us,
    • “A majority of transcatheter aortic valve replacement (TAVR) present with a history of heart failure (HF). According to new data published in the Journal of Cardiovascular Medicine, however, many of those patients are not being given the HF medications they need after undergoing TAVR.
    • “Cardiovascular morbidity and mortality remain high after TAVR,” wrote first author Elena Surkova, MD, MSc, PhD, a senior medical director at AstraZeneca and consultant cardiologist with Royal Brompton and Harefield Hospitals, and colleagues. “There is a lack of detailed data on the prevalence of HF in patients undergoing TAVR, medication prescription rates, including the main pillars of HF standard of care, and predictors of HF worsening following the procedure.”
  • The American Medical Association lets us know what doctors want patients to know about West Nile virus
    • “Most West Nile virus infections cause no symptoms, but some can lead to severe illness. Mosquito-bite prevention remains the best defense.”
  • MedPage Today adds,
    • “A gender gap historically seen in the suicide rates of 10- to 14-year-olds in the U.S. has tightened.
    • “In 2017, the suicide rate of boys was twice that of girls, but by 2024, it was only 4% higher.
    • “The author noted that the nearly equal suicide rates for 10- to 14-year-old boys and girls in the current study marked the “first time this has happened in the available records.”
  • Health Day notes,
    • “Autism spectrum disorder (ASD) diagnoses increased disproportionately among females after 2020, across age groups, while remaining stable or declining among males, according to a study published online July 22 in JAMA Network Open.
    • “Erick Messias, M.D., Ph.D., from St. Louis University, and colleagues evaluated age- and sex-specific incidence trends of ASD from 2016 to 2024 to quantify the temporal patterns before and after the COVID-19 pandemic. The analysis included electronic health record data from 171,134 individuals who had at least one clinical encounter annually at a large health care system.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a preclinical study by researchers at the University of East Anglia suggest that an experimental anticancer drug could stop osteoporosis and help women prevent weight gain after the menopause. Their study in mice found that the small molecule drug CADD522 not only protected against osteoporosis but could also reduce body fat and reverse some of the metabolic changes linked to menopause. Currently in development for cancer therapy, CADD522 is a small molecule inhibitor of the transcription factor RUNX2, which is helps to drive the growth and spread of several cancers.
    • “Research lead Darrell Green, PhD, at UEA’s Norwich Medical School, said, “We have uncovered an entirely new way of tackling the disease. We found that a drug originally developed to stop cancer could help millions of women facing the twin challenge of fragile bones and midlife weight gain. We hope our work could lead to a new generation of osteoporosis treatments that tackle bone loss while also addressing some of the wider metabolic consequences of menopause.”
    • “Green is senior and co-corresponding author of the team’s report in npj Drug Discovery, titled “RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss.” In their paper the team concluded that their collective studies “… identify RUNX2 inhibition as a therapeutic strategy that simultaneously improves skeletal integrity and metabolic homeostasis, supporting further development of CADD522 for osteoporosis and other RUNX2-driven diseases.”

From the U.S. healthcare business and artificial intelligence front,

  • The International Foundation of Employee Benefit Plans reports,
    • “Medical stop-loss premiums in 2026 show an increase from 13.6% on a $100,000 deductible to 15.9% on a $750,000 deductible, as reported by the 2026 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. Notably, this increase is approximately 5% to 5.5% higher than increases seen for the previous 2025 renewals. This impact was not surprising, as many underwriters reported increased severity and frequency in stop loss-claims in late 2024 and a resulting erosion in claims-to-premium loss ratios thereafter and throughout 2025. The survey captured necessary correction to 2026 premiums. The measured increases, rising alongside the size of deductible, reflect leveraged medical trend, as the underlying growth in expense of a catastrophic medical claimant is fully borne by an unchanged deductible.
    • “Survey response uniquely captures final, negotiated premium and reflects any pricing improvement from renewal marketings and concessions across all deductibles. In comparison, several large direct underwriters reported an average 2026 increase in the low 20% range on their own book-of-business. However, those are weighted by in-force policies unable to locate lower cost alternatives. The comparatively lower increases observed in this survey reflect the 2026 renewal rate opportunity found in the market. Looking ahead, an ongoing return to underwriter discipline and need to restore insurer loss ratios to a more profitable position does not indicate any easing on the 2027 renewal cycle.”
  • Fierce Pharma relates,
    • “Shifts in drug pricing and market access policies around the world have caused an “earthquake” that will reverberate for years to come, a survey of industry leaders found.
    • “Healthcare consultancy Numerof & Associates generated the insights in a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 
    • “While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years,” an executive said. “What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades.”
    • “Another executive characterized the policy environment as an “earthquake” that is “not going to settle down soon,” while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change. 
    • “The executives were talking after a succession of policy changes in key markets. Medicare gained the authority to directly negotiate prices for some drugs, and the most-favored-nation (MFN) policy tied U.S. prices to overseas markets.” 
  • Healthcare Dive tells us,
    • “UnitedHealthcare is still drilling down on actions it can take to make its Medicare Advantage plans more profitable next year, even as the insurer is expected to exit more underperforming geographies. But the company could be poised for growth in the markets where it remains, according to new comments from a top executive.
    • “We think we’re going to be very competitive in terms of our pricing next year,” CFO Wayne DeVeydt said during Wells Fargo’s annual healthcare conference Wednesday morning. “We think our benefits will be competitive … We still have a few markets where we’re right-sizing some of the products, but I think we’ll be well-positioned for 2027.”
    • “DeVeydt’s comments come as market watchers try to get a sense of how 2027 open enrollment will pan out, following an especially turbulent sign-up period for 2026 after insurers culled their plans in a bid to resuscitate flagging margins.”
  • Modern Healthcare adds,
    • “UnitedHealth Group and CVS Health are looking into acquisitions, executives said at a Wells Fargo conference.
    • “UnitedHealth Group identified value-based care companies and companies that would fit into its Optum Insight division as targets.
    • “CVS Health will seek “bolt-on” acquisitions and resume share buybacks next year.”
  • Beckers Payer Issues informs us,
    • “Anthem is now covering three surgical meshes for breast reconstruction, according to a clinical guideline published Aug. 27.
    • “DuraSorb Monofilament Mesh, GalaFLEX and TIGR Matrix Surgical Mesh “are considered medically necessary when used for breast reconstruction surgery,” the guidance said.
    • “We regularly review our medical coverage policies to ensure they’re aligned with credible medical evidence and the latest treatment standards and expert recommendations,” an Elevance Health spokesperson told Becker’s.” * * *
    • “ABC affiliate WFTS-TV in Tampa, Fla., has been reporting on breast cancer insurance denials, including for mesh, in recent years. It reported how Cigna updated its policy to cover mesh for breast reconstruction in 2025.
    • “Despite calls for insurer coverage, mesh for breast reconstruction has not secured FDA approval.”
  • and
    • “UnitedHealth Group’s Optum has sold interest in some of Optum’s Florida WellMed clinics to private equity company TPG, Bloomberg originally reported Sept. 9. UnitedHealth Chief Financial Officer Wayne DeVeydt told Bloomberg that the healthcare company was looking for a partner “that could actually work with us locally,” and UnitedHealth “didn’t need the dollars.” 
    • “We entered a strategic partnership designed to strengthen operating performance through dedicated support for clinic operations, targeted investments in technology and tools, and enhanced operating capabilities,” an Optum spokesperson told Becker’s Sept. 9. “The transitioning clinics will remain part of Optum’s network and continue providing high-quality care to patients. We remain committed to serving Florida patients through our integrated, value-based care model.”
  • Beckers Behavioral Health lets us know,
    • “Santa Fe, N.M.-based Quel Health launched a telehealth platform focused on using GLP-1 receptor agonists in addiction care. 
    • “The platform is available in 41 states and the District of Columbia, with national coverage planned by year-end, according to a Sept. 8 news release from the company. Quel also named Wernersville, Pa.-based Caron Treatment Centers a founding strategic partner.” * * *
    • “The approach follows work at Caron’s Pennsylvania and Florida campuses, where Steven Klein, MD, PhD, co-founder and chief medical officer of Quel Health, and his team evaluate GLP-1 receptor agonists in patients whose primary diagnosis was substance use disorder rather than obesity or diabetes.” 
       
  • Per Fierce Healthcare,
    • “Employers Health and Judi Health are teaming up to launch StarkRx, a new cost-plus benefit offering designed to drive transparency for employers.
    • “The approach unites the expertise of Employers Health as a group purchasing organization for pharmacy benefits that’s backed by employers with the technology available through Judi. The goal, the partners said, is to ensure that self-funded employers have greater access to transparency data that they can use to identify and manage cost drivers.
    • “Employers are expected to see another year of significant healthcare cost increases in 2027, with pharmaceuticals serving as a major factor behind the trend. A recent analysis from Marsh (formerly Mercer) estimated that costs could increase by 8.2% next year.
    • “Advanced, high-cost therapies and GLP-1 medications were both cited as key cost drivers in that analysis.”
  • and
    • “H1 has acquired Defacto Health, a healthcare data company focused on provider network intelligence, in a move to expand its offerings for health plans and strengthen its healthcare data assets.
    • “H1 is an AI-powered platform that brings healthcare data, domain expertise and an artificial intelligence platform to life science companies. The company built an AI-powered platform that helps identify and engage the right doctors for critical workflows across pharma, health plan, health system and technology companies. 
    • “Defacto Health is an AI-driven provider intelligence platform that aggregates and analyzes health insurance payer networks, provider directories and medical demographics data. The company maintains data on payer networks, healthcare providers and the insurance plans providers accept, helping health plans assess directory accuracy, isolate error clusters and benchmark their networks.”
  • Beckers Hospital Review reports,
    • “The American Medical Association released its 2027 Current Procedural Terminology (CPT) code set Sept. 9, an update that adds 299 codes and continues to build out billing for clinical AI.
    • “The set takes effect Jan. 1 and carries 453 total editorial changes: 299 new codes, 74 revisions and 80 deletions, the AMA said.
    • “Ten of the new codes describe AI-related services, raising the total number of AI-related CPT codes to 43. The AMA also updated Appendix S, its taxonomy that sorts medical AI by how much of the work the machine does — assistive, augmentative or autonomous — and guides how new tools get coded.
    • “As new technologies and clinical approaches emerge, the nation’s health system needs a reliable way to describe the care physicians provide,” said AMA President Willie Underwood III, MD. Dr. Underwood said a physician-led coding system gives that work “unmatched scale, expertise and legitimacy.”
    • “The set’s key clinical change, released in August, is a maternity coding overhaul that retires the decades-old global maternity bundle in favor of separate reporting across antepartum, labor, delivery and postpartum care.”
  • MedTech Dive offers “5 takeaways from Oura’s IPO filing.”
    • The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.
  • and tells us,
    • “Labcorp said Tuesday it has acquired MLM Medical Labs to add global central laboratory and biomarker capabilities for clinical trials.
    • “MLM is a global central and specialty laboratory provider with operations in the U.S., Germany and South Africa. 
    • “The deal makes Labcorp the only central laboratory provider with a wholly owned lab network across four continents, the acquiring company said. Neither party disclosed the financial terms of the deal.”

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, September 15, 2026, at 10:00 AM ET to consider Gerard Klomp to be Deputy Secretary of Health and Human Services (HHS); James Gadwood to be Chief Counsel for the Internal Revenue Service (IRS) and an Assistant General Counsel in the Department of the Treasury; Ge Bai to be an Assistant Secretary of HHS; and Andrew A. De Mello to be a Judge of the United States Tax Court.” * * *
    • “Opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • Beckers Hospital Review reports,
    • “HHS has selected four senior leaders for the FDA, including directors for the agency’s drug, biologics and tobacco centers and its first deputy commissioner focused on technology and artificial intelligence.
    • “Jared Seehafer was selected as the FDA’s first deputy commissioner for technology and artificial intelligence, according to a Sept. 8 HHS news release. He will serve as the agency’s senior leader for technology, software and AI and lead FDA-wide strategy and priorities in those areas.
    • “Michael Davis, MD, PhD, was selected as director of the Center for Drug Evaluation and Research after serving as acting director since May, when his predecessor was fired days after the agency’s commissioner stepped down. He will lead the center responsible for helping ensure safe, effective and high-quality drugs are available to the public.
    • “Karim Mikhail was selected as director of the Center for Biologics Evaluation and Research after serving as acting director, a post that has seen frequent turnover over the past year and a half. The center regulates biological products, including vaccines, blood and blood products and cellular and gene therapies.
    • “Bret Koplow, PhD, was selected as director of the Center for Tobacco Products after serving as acting director. He has served at the FDA since 2011.”
  • Behavioral Health Business informs us,
    • “The Trump administration today released guidelines on renewed enforcement efforts under the Mental Health Parity and Addiction Equity Act (MHPAEA), after halting enforcement of the law in 2025.  
    • “The latest guidelines are not the administration’s revised parity law, but rather a framework for enforcement action and identifying red flags during the interim. 
    • “A Sept. 8 bulletin from the Assistant Secretary for the Department of Labor’s Employee Benefits Security Administration (EBSA), Daniel Aronowitz, describes the agency’s intent to more substantially enforce the parity law’s nonquantitative treatment limitation (NQTL) requirements, which resulted from collective industry feedback.” * * *
    • “The renewed enforcement focus will fall into three buckets, identified as areas of enforcement need in a 2025 report from the agency to Congress: treatment limitations and exclusions; standards for medical necessity and review and standards for determining network adequacy, admissions and provider reimbursement methodologies.” 
  • Beckers Hospital Review tells us,
    • “ACA insurers requested a median rate increase of 15% for 2027, according to a Peterson-KFF Health System Tracker analysis. However, [as explained in the article,] some states are pushing back — while others are abiding by those requests — as they finalize increases.”

From the U.S. Office of Personnel Management front,

  • FedScoop reports,
    • “The Office of Personnel Management is looking to prevent data on the federal government’s public job board, USAJobs, from making its way onto misleading websites. 
    • “Last week, OPM updated terms of service for users of its USAJobs application programming interface (API) to include prohibitions on several actions related to the sale or redistribution of data from the website “to third parties as a standalone product or feed.” 
    • “Data provided to you through the API is for the explicit use of the requesting company or individual identified on the USAJOBS Program Office API Registration Form. No other use of the data provided is permitted without prior approval, in writing, from OPM USAJOBS,” said an emailed notice sent to API users, including FedScoop. 
    • ‘While the reason for that change wasn’t initially clear, an OPM spokesperson told FedScoop via email Friday that the policy change is aimed at preventing “unauthorized services that appear to be USAJOBS or allow users to apply for federal jobs outside USAJOBS.” 
  • Federal News Network interviews Tammy Flanagan about questions that federal and postal employees may have about their FEHB and PSHB coverage as they turn 65 years old.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Humana lodged a federal complaint Sept. 3 against Bayer AG and its acquired company, Monsanto, the business behind the weedkiller Roundup, seeking recoveries to address payments for Medicare Advantage members’ non-Hodgkin lymphoma-related care.
    • “Roundup’s active ingredient, glyphosate, has previously been linked to cancer risks. The lawsuit, filed in the U.S. District Court for the District of New Jersey, follows Monsanto’s proposed $7.25 billion settlement in February to resolve Roundup claims alleging non-Hodgkin lymphoma injuries. The settlement would act as a long-term compensation program, addressing current and future claims. Monsanto announced other settlement agreements in 2020, as well.
    • “However, Humana argues the February proposal does not confirm reimbursement for Medicare Advantage organizations that have already paid for relevant care. While the settlement acknowledges government payers, it establishes an “other insurers” category, including contracted payers. The complaint said this settlement lacks a “functional” lien-resolution program.”

From the fraud, waste, and abuse front,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “As part of the White House Anti-Fraud Task Force’s ongoing efforts to crush fraud in the healthcare system and protect taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) has identified and is barring 11 medical supply companies with more than $3.4 billion in suspected fraudulent billing practices in 2025 and 2026 from receiving future Medicare Advantage (MA) Part C and Part D payments. These 11 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers, (1) had submitted no claims prior to 2025; (2) used improper billing practices for their claims; (3) had billed for medical equipment to beneficiaries already deceased; and (4) supplied equipment to beneficiaries who never requested or received it. Four of the suppliers had already been revoked from Original Medicare and began billing Medicare Advantage plans instead.” 

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Albuquerque, N.M.-based Presbyterian Hospital said it found Legionella pneumophila in limited areas of the water system, including two rooms, Fox affiliate KRQE reported Sept. 7.
    • “The hospital implemented testing for the bacteria after a patient who recently received care at the hospital tested positive for Legionnaires’ disease. However, officials with the New Mexico Department of Health told CBS affiliate KOAT there is no definitive evidence showing the patient contracted the bacteria from Presbyterian. No additional cases have been identified and there is no known exposure to other patients or staff.
    • “The hospital received the environmental testing results Sept. 3 and immediately implemented safety precautions in affected areas.”
  • MedPage Today relates,
    • “Nicotine was long thought to fuel the inverse relationship between smoking and Parkinson’s disease.
    • “In this study, nonsmokers with high carbon monoxide (CO) levels had less Parkinson’s risk, suggesting CO may underlie smoking’s neuroprotective effects.
    • “The study followed more than 500,000 people for 12 years, measuring exhaled CO at baseline.”
  • and
    • “In a study of perimenopausal and recently postmenopausal women with vasomotor symptoms, initiation of menopausal hormone therapy (MHT) was associated with a 22% reduction in cardiovascular events.
    • “Notably, benefits were observed in those who initiated hormone therapy within 10 years of menopause onset and in Black women.
    • “The authors cautioned that given the lack of consistent cardiovascular benefit and the overall risk-benefit balance, the findings shouldn’t be used to support the use of MHT for cardiovascular prevention.”
  • Healio adds,
    • “Menopause remains inconsistently documented in electronic health records, according to a new systematic review published in Menopause.
    • “We expected to find some variation in how menopause was documented, but the extent of the inconsistency was striking,” Robin R. Austin, PhD, DNP, DC, MSN, RN, NI-BC, FAMIA, FAAN, an associate professor at the University of Minnesota School of Nursing, told Healio. “Menopause status and symptoms were often identified indirectly or incompletely, making it difficult to understand where a woman is in the menopause transition.”
  • Reuters tells us,
    • “Prescriptions for GLP-1 weight-loss drugs among children under 12 in the U.S. have risen more than 300-fold since 2019 as doctors seek new, effective ​treatments for younger patients with obesity, according to a study published on ‌Friday.
    • “The study, which included more than 3.5 million children aged between eight and 11 years with obesity but not diabetes, found that prescriptions for GLP-1 weight-loss drugs rose from 0.03% in ​2019 to 9.3% as of June.” * * *
    • “Although the drugs are not approved ​for use in children under 12 years, clinical guidelines allow the ⁠medications to be used for obesity in children as young as eight years ​old in certain cases.
    • “94% of the children prescribed GLP-1s had severe obesity, and ​about 65% had at least one related condition, such as high cholesterol, high blood pressure, and sleep apnea.” * * *
    • “While the absolute numbers of ​children under 12 receiving GLP-1 treatment is still low, the study shows that GLP-1 use ‌is ⁠accelerating rapidly, said lead investigator and obesity medicine specialist Dr. Babak Orandi of NYU Langone Health.”
  • Fierce Pharma adds,
    • Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
    • Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
    • Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
  • STAT News informs us,
    • “In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 
    • “Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.” 
  • BioPharma Dive adds,
    • “Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.”
  • and
    • “A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.”
  • Fierce Pharma notes,
    • “In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC).
    • “Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
    • “The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Although the highly contagious bacterium Clostridioides difficile (C. diff) causes severe disease in adults, it has been reported to not cause symptoms in infants. Based on that, the assumption has been that infant colonization was not a serious health issue. That said, the consequences of early-life colonization on host development remain unknown. Now, in a new study, researchers at Children’s Hospital of Philadelphia (CHOP) are challenging that long-held assumption, with new findings suggesting that the bacterium can reshape the developing infant gut and may have long-term consequences.
    • “This work was published in Science in the paper, “Early-life colonization with Clostridioides difficile remodels the developing gut.”
  • The New York Times points out,
    • “Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease.
    • “Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process.
    • “The molecular structure of the drug, called rentosertib, was generated with the assistance of A.I. Results of the new study, published Monday in the journal Nature Biotechnology, show that the drug reduced the biological markers of age as measured by six “aging clocks,” a different kind of A.I. technology designed to predict a person’s morbidity and mortality.
    • ‘This elaborate clinical trial is a milestone in the widespread effort to improve health care using the same A.I. techniques that underpin popular chatbots like ChatGPT and image generators like Midjourney. Insilico is just one of many start-ups, tech giants and academic labs working to accelerate drug discovery and honeother medical tasks with help from these methods.”
  • and
    • “It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation.
    • “Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed.
    • “All of this is possible thanks to the epigenome, a network of chemical tags throughout the body that latch on to DNA and tell each cell type how to behave. If a person’s DNA is a string of notes in a musical score, the epigenome is the collection of the conductor’s pencil markings left on the page — accumulated through experience over time, indicating which notes to play louder or softer or to skip entirely.”

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Growth in healthcare spending, not insurer profit margins, drove the vast majority of commercial premium increases over more than a decade, according to a study published Sept. 4 in JAMA Health Forum.
    • “Researchers at Yale University and the University of Wisconsin-Madison analyzed CMS data from 2011 to 2024 covering the large group, small group and individual markets, which included information on premiums, health spending and insurer markups for each state and year. The data did not include self-insured employers, which cover roughly half the U.S. population.”
  • Fierce Healthcare relates,
    • “After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing.
    • “Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist.
    • “Hug balked at the $18,000 estimate.
    • “The estimate for the in-office procedure was around $3,000. The bill when she was forced at the last minute to switch to the surgery center was around $6,000. She now wonders, “How is it legal for these hospitals to force patients to have procedures done in a hospital when professional organizations recommend differently?”
    • “Hug’s experience is a classic example of the predicted outcome of “vertical integration” in the healthcare system, when one company owns or controls multiple parts of a supply chain and can therefore direct patients to more expensive treatment options.”
  • Beckers ASC Review tells us,
    • “Twenty-seven states [listed in the article] have opted out of the federal requirement that a physician supervise CRNAs administering anesthesia, according to the American Association of Nurse Anesthesiology’s most recent fact sheet, updated in July 2026.
    • “Vermont and Ohio became the 26th and 27th states to opt out, making the move in July 2026. The full list stretches back more than two decades, and for ASC leaders dealing with anesthesia staffing costs, where a state falls on that list is directly relevant to how much flexibility they have to restructure anesthesia coverage.” * * *
    • “In opt-out states — provided state law and facility policy also allow it — ASCs have more room to build CRNA-based staffing model models. Seattle-based Proliance Surgeons moved to a CRNA-only staffing model in 2025 after the anesthesiology group it was partnered with decided not to renew its contract. After switching the new model, the organization reported no patient care delays and no cases redirected to hospitals over provider-availability concerns.
    • ‘That’s just one case study, but as more states move away from the federal supervision requirement, the staffing-model conversation for ASCs is likely to keep shifting from “how much do we pay for anesthesiologist coverage” to “do we need anesthesiologist coverage for this case mix at all.”
  • The American Hospital Association News notes,
    • “A report on obstetric services in hospitals by the University of Minnesota Rural Health Research Center found that between 2010 and 2024, 718 hospitals nationwide lost obstetric services due to obstetric unit or hospital closure. The report found that 9% of those losses happened from 2023-2024. Between 2010-2024, 14% of hospitals (16% of rural hospitals, 13% of urban hospitals) lost obstetric services, while 35% (42% rural, 30% urban) never had obstetric services during that period. By 2024, 57.5% of rural hospitals and 43.6% of urban hospitals across the U.S. were without obstetric services.” 
  • Healthcare IT News explains how “telemedicine becomes more deeply embedded into hospital workflows.”
    • “Health systems are using virtual nursing, tele-ICU, remote specialty care and EHR-integrated teams to extend scarce expertise, support bedside clinicians and redesign care delivery.”
  • Beckers Physician Leadership discusses the “uneven collapse of private medical practice.”
    • “While the decline of independent practice has persisted as a general trend across medicine, the consolidation of physician practices has played out differently across specialties. 
    • “A 2025 specialty-level breakdown of independent practice published by the American Medical Association found private-practice rates ranging from 70.4% in ophthalmology down to 30.7% in gastroenterology, a nearly 40-percentage-point gap between the most and least independent of the five specialties driving the bulk of physician practice mergers and acquisitions activity.”
  • Fierce Healthcare informs us,
    • “Oura, the smart ring maker and health tracking company, filed to go public on Thursday [September 10] to fuel its next phase of growth as it aims to build an artificial intelligence-powered health platform.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering. Oura intends to list on the Nasdaq under the ticker symbol “OURA.”
    • “Founded in Finland in 2013, Oura’s smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health.”
  • and
    • “Five Kansas health systems have launched a regional collaboration, called Astra Health, to pool resources and coordinate services while retaining their independence. 
    • “The new shared services organization was announced Tuesday and will include LMH Health, The University of Kansas Health System, Amberwell Health, Newman Regional Health and Salina Regional Health Center. Together, the organizations see more than half a million patients annually and extend into every county in the state. 
    • “The partnership will help participating hospitals improve quality, share best practices, enhance performance measurement, and strengthen care delivery in the communities they serve,” Shelly Kortkamp, M.D., president and CEO of LMH Health, said in an announcement.”
  • and
    • “Health tech startup Forus banked $150 million in series C funding as it aims to expand its artificial intelligence-powered network to more medical specialties and care settings.
    • “The fresh funding comes just four months after the company announced it raised $160 million in a series B round. The latest funding round boosts Forus’ valuation to $3 billion, tripling from its series B round in May, according to the company. Forus has raised more than $300 million to date.
    • “Bain Capital Ventures, an investor in Forus since its seed round, led the latest round, with every existing institutional investor reinvesting, including Thrive Capital, General Catalyst, Accel, Redpoint, BoxGroup, Pear VC, Vast Ventures and SV Angel.”
  • Per BioPharma Dive,
    • “BrainChild Bio, a cell therapy developer making CAR-T treatments for children with rare brain cancers, has banked $116 million in a round of venture financing, the company announced Tuesday.
    • “CAR-T therapies are powerful treatments engineered from immune cells. A handful have been approved to treat certain blood cancers, and many companies are studying their potential on other tumors and even autoimmune diseases.
    • “But according to BrainChild founder and Chief Scientific Officer Michael Jensen, few companies have tried to test CAR-T treatments against brain cancer. “The prejudice is that the brain would be intolerant to having cells directly administered,” he said. 
    • “BrainChild is different. Spun out of research at Seattle Children’s Hospital three years ago, the company is working on a pair of brain cancer cell therapies designed specifically for children.”
  • Per Fierce Pharma,
    • “Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years. 
    • “Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
    • “Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.” 
  • Tech Target offers “6 use cases for improving employee retention using predictive analytics.”
    • Predictive analytics can identify employees who are good candidates for promotion. Learn other use cases for improving employee retention using predictive analytics.

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state. 
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Weekend update

David Ermer–Congress, COVID-19, FDA, Obesity, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • This is the last week that both Houses of Congress are out of town on State/District work period. The House of Representatives returns to Capitol Hill on August 31 and the Senate returns on September 14. Both Houses head out on the campaign trail on October 1 until the week following the national election day on November 2.
  • Global BioDefense reports,
    • “The federal government wants to lock in vaccine manufacturers now, well before the next flu pandemic arrives, rather than scramble to build production capacity after one begins. The Biomedical Advanced Research and Development Authority (BARDA) released a request for proposals on August 17 seeking companies to maintain what the agency calls warm base manufacturing capacity for pandemic influenza vaccines, a standing readiness posture that keeps production lines, seed stocks, and regulatory groundwork in place so doses can start flowing quickly once a pandemic strain emerges.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “After receiving Europe’s CE mark earlier this year, Abbott is preparing to bring a dual glucose-ketone sensor to the U.S.
    • “The company has filed an application for its new device, called Libre Duo, with the Food and Drug Administration, with expectations for approval before the end of the year.
    • “Abbott hopes that by allowing people to be more aware of ketone levels, the new device will help prevent diabetic ketoacidosis, or DKA, a serious complication of diabetes where the body lacks insulin. However, broader access to ketone measurement also brings questions around best practices for interpreting and acting on this new data.”
    • MedTech Dive interviews endrinologists about this development in the article. 

From the public health and medical / Rx research front

  • Tech Times lets us know where with stand with the summer Covid surge and what it means for the fall season.
  • Medscape relates,
    • “Adults on GLP-1s who lost weight during their first year on the medications are likely to maintain that loss through the second year of use, according to two new Cosmos studies.
    • “That finding was true for those with diabetes and without.
    • “We did observe that patients without diabetes had higher rates of maintaining that weight loss,” said Kersten Bartelt, RN, a researcher at Epic Research and a coauthor on both studies. And those on tirzepatide had lower rates of weight regain that those on semaglutide, the two medications studied.
    • “Bottom line? Continued use of GLP-1s means continued weight loss benefit or maintenance, Bartelt said.”
  • STAT News tells us,
    • “If you could design an oral treatment that limits appetite and mimics some effects of physical activity, you might call it exercise in a pill. Now a company is releasing early results for a compound to do just that.
    • “The pill, the company hopes, can maintain weight loss without the common gastrointestinal effects of GLP-1s. The component of exercise it is designed to re-create is preservation of lean muscle mass, a concern when people yo-yo on and off GLP-1 drugs, losing more muscle each time.
    • “Those researchers showed in a 2022 Nature paper that lac-phe can suppress appetite and lower obesity in animals. Lac-phe and ENV-308, Enveda’s chemically engineered version, both act on leptin, a hormone that has been the target of scientists and drug developers for decades. If confirmed in clinical trials, the company says, ENV-308 would be the first “leptin sensitizer in a pill.” 
    • “ENV308 is our attempt to put the chemistry of exercise into a daily tablet,” said Viswa Colluru, Enveda’s founder and CEO.”

From the U.S. healthcare business front,

  • Kaufmann Hall released its 2nd Quarter 2026 Physicians’ Flash Report last week.
    • The investment curve for providers has flattened. The investment/subsidy per both provider and physician has remained steady year-over-year, a positive sign for medical group performance.
    • Advanced practice providers (APPs) are helping control costs. The number of APPs continues to steadily increase, now making up 41.2% of the Total Provider FTEs represented in this sample. As medical groups continue to design strategic APP and physician staffing models, organizations may continue to see stronger returns in overall team effectiveness, productivity, and cost control.
    • Continued increases in productivity are offsetting expense growth but stretching providers. Physician and provider (APPs or otherwise) work relative value units (wRVUs) per FTE grew 3% and 2%, respectively, showing continued increases in productivity. While this may drive revenue to help offset expense growth, it can also increase burnout and impact quality of care.
    • Support staff levels continue to tighten, leaving providers to absorb more work. Support staff expense fell slightly, reflecting ongoing hiring and retention challenges. As staffing tightens, physicians and APPs may need to take on more non-clinical tasks, presenting challenges in working at the top of their license.
  • An AHIP news release adds,
    • “Each year brand drugmakers make tens of millions of dollars in payments to physicians— consulting fees, speaking honoraria, meals, travel and more. A new analysis of disclosures from 10 of the largest brand drugmakers, contained within the Centers for Medicare & Medicaid Services (CMS) Open Payments data, reveals these manufacturers spent nearly $200 million on payments to more than half a million physicians in 2024 alone.
    • “CMS data shows that physicians receiving payments from these 10 brand manufacturers then billed fee-for-service Medicare nearly $45 billion for drugs made by those same manufacturers in 2024. The return on investment for those manufacturers was a staggering $220 in sales for every dollar in physician payments. 
    • “This analysis builds on mounting evidence that physicians who receive manufacturer payments prescribe more drugs sold by those manufacturers.” 

Friday report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “Mark Cruz was named the director of HHS’ Indian Health Service, according to an Aug. 21 news release.
    • “The Senate confirmed Mr. Cruz on Aug. 7 following President Donald Trump’s June 1 nomination. President Trump has since signed the commission granting him the role.
    • “Mr. Cruz, a citizen of the Klamath Tribes, will have a four-year term. The position had been empty since January 2025, and Mr. Cruz is the agency’s 12th Senate-confirmed director.
    • “IHS, the country’s 18th largest public health system, provides healthcare services to roughly 2.8 million American Indians and Alaska Natives across nearly 600 federally run hospitals and clinics, tribal health programs and urban Indian organizations.”
  • STAT News relates,
    • “President Trump and health secretary Robert F. Kennedy Jr. are pressing ahead with efforts to change how kids in the U.S. get their shots. 
    • “The latest move, a request for information posted Friday, offers more clues to Kennedy and Trump’s vision for vaccine policy, and shows that pursuing changes is a priority. It does not make any changes itself, but it asks for feedback on a wide variety of ideas. It gives the public 30 days to comment.
    • “Among the questions it asks the public to consider is whether there should be new categories to the vaccines framework, which currently includes universal recommendations, recommendations for certain risk-based groups, and recommendations based on shared clinical decision-making.” * * *
    • “On Friday, the White House unveiled a new website celebrating 555 days of the Make America Healthy Again movement (Friday marks 555 days since Kennedy was confirmed as HHS secretary). Among the list of achievements is “delivering gold standard childhood vaccine recommendations,” touting the executive order for solving a purported problem: that the U.S. recommends more vaccines than other peer nation.”
       
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced the development of the first-ever National Autism Missing and Endangered Person Alert initiative. Led by HHS in partnership with the U.S. Department of Justice (DOJ) and the Federal Emergency Management Agency (FEMA) under the Department of Homeland Security (DHS), the initiative will work to strengthen coordination among emergency management agencies, law enforcement, first responders, and community partners nationwide to improve preparedness and response when autistic individuals are reported missing. It will also establish a national framework of best practices to address the leading causes of preventable injury and death among autistic individuals, which include accidental drowning linked to wandering and elopement.
    • “When an autistic child or adult goes missing, every minute matters,” said Secretary Kennedy. “President Trump has made improving the lives of Americans with autism and their families a priority. We are bringing federal, state, and local partners together to improve prevention, speed the response, and help bring autistic children and adults home safely.”
  • McKinsey & Company interviews Seema Verma about advancing American healthcare.
    • “A former CMS administrator and current Oracle Health and Life Sciences executive discusses leadership, public–private collaboration, and the promise of AI and value-based care.”
  • MedTech Dive tells us,
    • “Siemens Healthineers and Philips North America are among a group of companies and universities that will receive funding from the Advanced Research Projects Agency for Health to develop autonomous endovascular robotics to treat stroke patients.
    • “The federal awards, totaling up to $175.3 million over five years, are intended to further research on technology to bring faster stroke treatment to more people. Siemens’ work would enable robots to perform long-distance treatment of acute ischemic stroke through mechanical thrombectomy without direct human input, the company said Thursday.
    • “Stryker, which established a strategic partnership with Siemens Healthineers last year to develop robotic neurovascular interventions, is a subrecipient in the project, Siemens Healthineers said. Others receiving ARPA-H funds for robotic stroke treatment include MIT spinout Magnendo and the University of California, San Diego.”

From the U.S. Office of Personnel Management front,

  • OPM Director Scott Kupor added another post (Substack link) to his Secrets of OPM blog today. This post concerns artificial intelligence.
    • “AI adoption is measurable with three metrics — and the numbers tell you what to do next.
    • “Nobody at your agency has a Microsoft Word adoption strategy. Word is simply how documents get written, the way email is how messages move. My theory is that AI becomes part of the operating system of how work gets done. Broadly used, barely remarked on.
    • “So, how do we get there? We need metrics to understand where we stand and guide our next steps. Our signals come from three questions. Do people use the tools? Do they like them — do they feel the tools help them do the work? Is the business better? Use, sentiment, impact. That is the whole framework.”
  • Federal News Network asks “Are you getting the most out of your TSP? Probably not — here’s how to change that.”
    • Being aware of a few lesser-known tricks and pitfalls can help federal employees get the most out of their TSP, and subsequently, their retirement.

From the Food and Drug Administration front

  • BioSpace reports,
    • “Three fatalities occurring recently in China clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.
    • “After three patient deaths were reported in separate gene therapy clinical trials in China, two members of the House of Representatives are asking the FDA to implement specific measures to lower patient risk in the U.S.
    • “Reps. John Moolenaar (R-MI) and Ben Cline (R-VA) have reportedly penned a letter to Acting FDA Commissioner Kyle Diamantas, writing that “accepting Chinese clinical data poses real risks for patients,” according to Endpoints News.
    • “The two lawmakers are asking the agency to reject clinical data from China unless the trial site has recently undergone an FDA audit, and to also conduct a wide-ranging review of products that have received U.S. approval based on clinical results from China, according to the letter obtained by Endpoints.”
  • Newsweek relates,
    • “The Food and Drug Administration (FDA) has given a recall of popular Whole Foods dips its highest risk classification, warning that consuming the items could cause “serious adverse health consequences or death.”
    • “The recall, which Whole Foods issued earlier this month, involves products containing jalapeños—such as guacamole and pico de gallo—sourced from Coast Citrus Distributors, a wholesale fresh produce supplier operating across the U.S. and Mexico. The jalapeños are believed to be potentially contaminated with salmonella bacteria.
    • “After the first few cases of salmonella were reported across the country over the summer, federal investigators identified a grower in Sinaloa, Mexico, as the potential source of contamination.” 
  • The American Hospital Association tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine Hydrochloride in Dextrose Injection, which has also been recalled. As of April 24, B. Braun reported 35 serious injuries and no deaths associated with the issue. Medline had not reported any additional serious injuries or deaths associated with the issue as of June 19, the FDA said.”
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall for Boston Scientific’s Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus. The recall was put in place due to a risk of arterial sheath tip separation or partial tip separation during use. One serious injury has been linked to this issue.
    • “The FDA first warned the public about these risks in July as part of its Early Alert pilot program. The issue was still under investigation at that time. Now, the agency has reached its conclusion that this is a Class I recall, which means these devices are associated with a risk of “serious adverse health consequences or death.”  
    • “This recall includes more than 115,000 units of the Enroute Transcarotid Neuroprotection System and nearly 50,000 units of the Enroute Transcarotid Neuroprotection System Plus. Customers with any of these devices on hand should stop using them right away and start the process of returning them to Boston Scientific. If customers know of any Enroute systems forwarded from one facility to the next, they should communicate with that facility about this concern.
    • “Click here for more information from the FDA, including specific lot numbers.”
  • Newswise informs us,
    • “The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative blood test with underlying technology invented at Washington University School of Medicine in St. Louis for the early diagnosis of Alzheimer’s disease. The test, known as PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup company.
    • “PrecivityAD2 is a blood-based diagnostic test cleared by the FDA to aid in identifying the presence of amyloid plaques in the brain associated with Alzheimer’s disease in certain patients. Unlike some other FDA-cleared blood-based tests that use immunoassay methods to analyze biomarkers associated with Alzheimer’s, PrecivityAD2 uses high-resolution mass spectrometry to provide quantitative measurements of the biomarkers.
    • “The availability of blood-based biomarker testing may help clinicians evaluate patients for Alzheimer’s disease using a less invasive approach than cerebrospinal fluid testing. Biomarker information may also help inform appropriate clinical management when interpreted together with a patient’s clinical history and other diagnostic information.”

From the public health and medical / Rx research

  • The Centers for Disease Control and Prevention announced today
    • “As of August 21, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “National and regional COVID-19 activity is increasing.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally. Parainfluenza virus (PIV) is elevated in some regions.”
  • CNN adds,
    • Are you coughing, hacking or feeling feverish? It may not be just a summer cold; you might want to consider taking a Covid test.
    • Although the autumn respiratory illness season hasn’t kicked off, and flu and RSV activity remain low, there’s a growing summer wave of Covid-19.
    • Case numbers aren’t especially high, and the United States isn’t recording many hospitalizations or deaths. But data from the US Centers for Disease Control and Prevention puts the test positivity rate for the week ending August 8 above 3% for the first time since March, with numbers climbing in every state.
    • “August is solidly Covid season,” said Dr. Caitlin Rivers, an expert in outbreak science and senior scholar at the Johns Hopkins Center for Health and Security. “Right now, the South and the West are sort of the leading edge of this Covid season. In the past, it almost always starts in Florida, Texas and Georgia, which is exactly what we’re seeing this year.”
  • The University of Minnesota CIDRAP reports,
    • “The rapidly rising US measles outbreak grew to 2,777 cases today as the Centers for Disease Control and Prevention (CDC) confirmed 211 new infections in its weekly update.
    • “The increase is more than double that seen last week, when the agency added 101 cases to the total, after adding 94 the week before. Most of this week’s cases are in Pennsylvania and Ohio. 
    • “The CDC noted 36 outbreaks, which might be an anomaly, as a week ago the agency had logged 38 for the year. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level a month ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 66% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 94% are unvaccinated or have an unknown vaccine status. 
    • “No measles deaths have been reported this year. Last year, three people, including two children, died of measles, one of the most transmissible diseases known.”
  • The American Hospital Association News lets us know,
    • “There have been 15,716 confirmed cases of cyclosporiasis across 47 states, Washington, D.C., and Puerto Rico since May 1, the Centers for Disease Control and Prevention data reported Aug. 18. There have been 828 hospitalizations. The agency said there are at least 11,841 additional cases that require further investigation. Two people have died from the multistate cyclosporiasis outbreak linked to iceberg lettuce.” 
  • USA Today adds,
    • “While these numbers show that confirmed cases themselves are still rising, the overall trend is on a downward swing; previous weeks regularly saw increase that numbered into the 2,000 and 3,000 range.”
  • The Washington Post provides more context,
    • “Federal officials said Thursday that recalled Taylor Farms lettuce linked to a large cyclospora outbreak may have been distributed to nine additional jurisdictions, expanding the potential reach of contaminated products.
    • “The best-by dates for these recalled products have passed, officials said, and they should no longer be available for sale in stores or restaurants. Consumers who previously bought or received food items with the recalled iceberg lettuce should carefully clean and sanitize any surfaces or containers that it may have touched.
    • “The expanded distribution information provides a fuller picture of where the recalled lettuce may have traveled than was known when Taylor Farms de Mexico announced a voluntary recall July 17. The company removed iceberg lettuce sourced from central Mexico from the U.S. market after it was linked to the outbreak and said it had been distributed to 27 states.”
  • The Wall Street Journal points out,
    • “An outbreak of E. coli and salmonella linked to alfalfa sprouts has sickened dozens of people across 15 states, public-health officials said. 
    • “The Centers for Disease Control and Prevention on Friday urged consumers not to eat alfalfa sprouts grown by Everything Sprouts and sold under the Calco and Everything Sprouts brands. Fifty-five people have been infected with E. coli or salmonella in connection with the outbreak, the health agency said, including two people who contracted both pathogens. 
    • “No one has died in the outbreak, the CDC said. Four people have been hospitalized.” 
  • Beckers Clinical Leadership tells us,
    • “The American College of Obstetricians and Gynecologists has released updated guidelines supporting fallopian tube removal to reduce ovarian cancer risk. 
    • “The updated guidance was published Aug. 20 in Obstetrics & Gynecology.  The move comes after a study found fallopian tube removal can reduce patients’ ovarian cancer risk by almost 80%.
    • “Common procedures inside the abdomen or pelvis, including hysterectomy, tubal procedures for permanent contraception and non-gynecologic surgeries, offer opportunities for patients to reduce their risk of ovarian cancer through salpingectomy,” ACOG said in an Aug. 20 news release.
    • “Read the full updated guidance here.”
  • Health Day adds,
    • “Could a diet rich in antioxidants help women lower their risk of cervical cancer?
    • “A new study suggests these compounds may play a role in preventing the disease, the fifth-most commonly diagnosed cancer in women globally.
    • “A team led by Maozhu Lang of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing analyzed data from more than 1,000 U.S. women who took part in national health and nutrition surveys between 2003 and 2018. Some had a history of cervical cancer. Others did not.
    • “Researchers looked at their intake of vitamins A, C and E, zinc, selenium and carotenoids — antioxidants found in foods such as fruits, vegetables and whole grains.
    • “The result: Those with the highest antioxidant intake had nearly 56% lower prevalence of cervical cancer compared to those with the lowest intake.”
  • The University of Minnesota informs us,
    • “People vaccinated against the human papillomavirus (HPV) were much less likely to develop cancers of the head and neck, according to a study published this week in the International Journal of Infectious Diseases. 
    • “The study confirms earlier research finding a vaccine-related decrease in head and neck cancers.
    • “The new study analyzed 1.4 million medical records from 66 US healthcare organizations. Half of the research subjects were vaccinated against HPV from ages 9 to 45. The other half were vaccinated against other diseases but not HPV. Study participants were vaccinated from January 2011 to June 2024. 
    • “People vaccinated from age 9 to 26 years—the age range recommended by the American Academy of Pediatrics—were 68% less likely to be diagnosed as having head or neck cancer, according to the study.
    • “There was no statistically significant reduction in head and neck cancers in people vaccinated from age 27 to 45, most likely because these people had been exposed to HPV before being immunized, said Ching-Nung Wu, MD, PhD, first author of the paper and an otolaryngologist at Kaohsiung Chang Gung Memorial Hospital in Taiwan.”
  • The New York Times notes,
    • “There’s about a two- to threefold increased risk of developing dementia if you have epilepsy,” said Dr. Alice Lam, an associate professor of neurology at Harvard Medical School. And “if you have dementia, you have, on average, a two- to threefold increased risk of developing seizures.”
    • “Links between epilepsy and dementia — conditions that affect millions and are more prevalent in older age — are increasingly crucial to recognize as people live longer, experts say.
    • “It’s a super important, super common thing around the world, and yet it really, really does not get attention,” said Dr. Arjune Sen, a professor of global epilepsy at the University of Oxford.”

From the U.S. healthcare business and artificial intelligence front

  • Beckers Hospital Review reports,
    • “Rochester, Minn.-based Mayo Clinic recorded operating income of $501 million (8.6% operating margin) in the second quarter of 2026, up from $394 million (7.4% margin) during the same period last year, according to its Aug. 21 financial report. 
  • and
    • ‘BradenHealth has acquired the former Jellico (Tenn.) Hospital, with plans to reopen it as a full-service hospital.
    • “The purchase from the City of Jellico is a minimum $14 million investment and is expected to create about 120 jobs, according to an Aug. 21 BradenHealth news release shared with Becker’s.
    • “Jellico Hospital’s closure left a painful gap in access for families who already face significant barriers to care,” Founder and CEO Beau Braden, DO, said in the release. “We did not acquire this facility to simply reopen doors; we acquired it to rebuild a reliable, high-quality healthcare presence that the people of this region can count on.”
  • Business Insider points out,
    • Disney is joining other big-name companies in curbing employee benefits, a move that comes as healthcare costs rise.
    • Starting next year, the entertainment giant will no longer offer medical insurance plans to US employees’ spouses if their spouses have jobs that provide such coverage, a Disney spokesperson confirmed to Business Insider. Employees’ other dependents won’t be impacted.
    • “Like a growing number of large employers, we’re making measured adjustments to our employee benefits in response to rising healthcare costs nationwide,” the company said in a statement.
  • Fierce Pharma relates,
    • “After a one-week hiccup, Novo Nordisk’s Wegovy pill regained its momentum last week with its largest prescription rate since it was launched in January. There were more than 176,000 prescriptions for the pill in the period, according to data gathered by IQVIA and cited in a note by Citi. 
    • “The oral treatment now accounts for 35% of total Wegovy prescriptions, which is up from 33% the previous week, analysts from Citi said in their weekly update to investors.
    • “Meanwhile, Eli Lilly’s oral GLP-1 Foundayo, which had been on a steady five-week climb, backtracked, with a drop-off from 38,928 prescriptions in the prior period to 36,620 in the latest week.
    • “The movements for the two oral treatments contributed to overall market share adjustments for the companies’ diabetes and obesity medicines. While Lilly made a 0.1% gain to 56.7%, Novo increased its market share by 0.3% to 37.1%.” 
  • Beckers Hospital Review notes,
    • “Health systems have spent two years debating which AI tools to buy. The executives running them are starting to question how often they need to revisit that decision.
    • “Richard Mulry, president and CEO of Northwell Holdings in New Hyde Park, N.Y., sees the cycle speeding up as the cost structure around AI changes.
    • “The most dangerous trend in healthcare right now is borrowed conviction: letting someone else’s roadmap, or someone else’s press release, stand in for your own operating strategy,” Mr. Mulry said. “AI has created a kind of gravitational pull where the fear of being late is doing more to pressure capital allocation than the actual problems in front of us.”
    • “The pressure produces two failure modes that look like opposites. One is premature commitment — investing early in solutions that will eventually be absorbed into core platforms, leaving organizations managing technical debt with no lasting strategic value. The other is waiting for platform vendors to deliver while nothing changes in the workforce, the workflows, or the cost structure.
    • “Participation driven by optics and paralysis look like opposites, but we’ve come to see them as the same failure: outsourcing judgment to the market’s clock instead of your own operating priorities,” Mr. Mulry said.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “Lawmakers are sounding the alarm over the nation’s $40 trillion debt, lamenting Congress’s inability to meaningfully confront a problem that has grown increasingly difficult to ignore.
    • “Both parties have spent years trying to tackle the rising debt. Republicans have frequently pointed to federal spending and entitlement programs as the main drivers, while Democrats have emphasized the need for higher taxes on wealthy Americans and corporations alongside spending reforms.
    • “But efforts to reach a broader deal have repeatedly stalled as both parties have balked at the politically painful trade-offs needed to put the nation on a more sustainable fiscal path.” 
  • Modern Healthcare relates,
    • “A Senate bill [S. 3097 – Health Information Privacy Reform Act] would create medical privacy protections for consumer health products such as wearables and wellness apps.
    • “The legislation unanimously passed the Senate health committee last month and a similar bill is pending in the House.
    • “Stronger privacy rules could hamper some tech companies while benefiting others as well as providers eager to tap into new technology.”
  • Per a CMS news release,
    • “The Trump Administration announced an additional $4.2 million, made possible through the federal Rural Health Transformation Program (RHTP), is being put to work in West Virginia to expand patients’ transportation options and remove service barriers.
    • “By injecting millions into the Rural Health Link initiative, the Administration is upending the status quo that has limited transportation options for residents in need of critical healthcare services and delivering on its commitment to West Virginians who deserve the best access to care no matter their zip code. These funds will help increase medical transportation capacity, service availability, and improve geographic coverage for patients across the Mountain State.” 

From the U.S. Office of Personnel Management front,

  • Today’s Washington Post included an oped written by OPM Director Scott Kupor about his agency’s efforts to improve the merit system.
    • “At the Office of Personnel Management — Washington’s chief HR agency — my team has spent the past 20 months reforming this system. Our goal is simple and uncontroversial: Merit matters, not how long employees have been in a role or what college degree they earned, both in hiring and in day-to-day performance. That means accountability for employees who can’t deliver and distinction for those who knock the cover off the ball.”
  • Govexec adds,
    • “An agency spokeswoman said that a four-person communications team — all under the age of 30 — is spearheading the effort to make OPM’s social media more appealing to younger potential hires.”
  • Tammy Flanagan writing in Govexec, lets us know,
    • “Retiring from federal service is a major milestone, of course, but it does not end the need to understand how federal benefits work. In the years after retirement, life events and new opportunities can raise important questions about insurance, survivor benefits, beneficiary designations and the effect of returning to government employment.
    • “Today I will highlight several post-retirement issues that federal employees may want to plan for in advance. This is not an all-inclusive list, but it’s a list that will hopefully remind you that it is important to review your benefits and be sure to understand how they can change as life goes on.” * * *
    • “Health benefits can also change after retirement, not only the premiums and the benefits, but your needs may change over time. Outside of open season, FEHB changes generally must be tied to a Qualifying Life Event (QLE), such as marriage, divorce, death of a family member, or a move out of a plan’s service area, and many changes must be requested within 60 days of the event.
    • “Annuitants should confirm the effective date with OPM because the timing can depend on the type of change. For example, some enrollment decreases may be made at any time and are commonly effective at the beginning of the month after OPM receives the election, while other changes follow the qualifying life event rules.
    • “There is a little-known option to change insurance just because you have reached age 65, it is QLE 2L. This is your “ace in the hole” that you can only use once in your lifetime to change plans outside of open season.
    • “This is generally used to change plans when enrolling in Medicare after retirement, but if not used at age 65, it can be used later – but only once!”

From the Food and Drug Administration front,

  • CBS News reports,
    • “A New York-based consumer healthcare company is recalling nearly 40,000 bottles of eye drops over concerns about the product’s sterility. 
    • “Prestige Consumer Healthcare initiated the recall on July 29 due to “lack of assurance of sterility,” according to a U.S. Food and Drug Administration notice.
    • “The recall is due to potential contamination,” the notice says.
    • “The recall affects 15mL bottles of Clear Eyes’ Maximum Itchy Eye Relief, which mitigates itchiness, redness and other eye irritations, according to the product description. The eye drops were distributed nationwide.”
  • Fierce Pharma relates,
    • “If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. 
    • “Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos. 
    • “The accelerated approval specifically covers the gene therapy—previously coded as DTX401—in adults and kids over the age of 8 years with GSDIa, an ultrarare genetic disorder driven by a deficiency of the enzyme G6PC, which is needed to release glucose from the liver into the bloodstream. The liver is less capable of controlling glucose levels in these patients, leading to potentially life-threatening hypoglycemia episodes and other complications. 
    • “By Ultragenyx’s reckoning, there are between 1,500 and 2,500 people living with GSDIa in the U.S. out of an estimated global patient population of 6,000 to 8,000 “within commercially accessible geographies,” the company said in an Aug. 19 release.” 
  • HCPLive tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon’s Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
    • “The approval of fluticasone propionate nasal spray, USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” * * *
    • “FDA approval was secured through the bioequivalence pathway, so no independent clinical efficacy or safety program accompanied authorization beyond equivalence to the reference product.” * * *
    • “Distribution will be handled by Glenmark Pharmaceuticals Inc., USA, while pricing and launch timing were not disclosed.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A growing number of Americans say their cannabis use is problematic, according to a large new study released Wednesday.
    • “The study, based on nationally representative data of U.S. adults, found that more than 9 percent of the men — or almost 1 in 10 — reported symptoms of cannabis use disorder in 2024, up from about 7 percent in 2021. The prevalence of cannabis use disorder also rose among women, increasing to nearly 6 percent in 2024, up from about 5 percent in 2021. Symptoms of the disorder include not being able to cut back or quit, or continuing to use the drug despite it leading to interpersonal problems.
    • “The notion that cannabis is not addictive may basically be incorrect,” said Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse and the paper’s senior author.”
  • and
    • “There is no one-size-fits-all approach to managing treatment-resistant depression.
    • “At the UC Davis clinic, if patients don’t improve after trying two antidepressants in succession and undergoing psychotherapy, they may be prescribed a low dose of an additional drug such as an atypical antipsychotic or lithium, Dr. Debra Kahn, director of the Advanced Psychiatric Therapeutics Clinic at UC Davis Health said. Clinicians will ensure that medical problems that could be contributing to symptoms are addressed, too.
    • “One additional therapy that has been shown to help people with treatment-resistant depression is transcranial magnetic stimulation, or T.M.S., which was cleared by the U.S. Food and Drug Administration to treat depression in 2008, Dr. Kahn said. It uses magnetic pulses to stimulate parts of the brain to release mood-boosting chemicals including norepinephrine, dopamine and serotonin, she said.
    • “T.M.S. is tolerated well and has no long-term serious side effects, Dr. Kahn said. * * *
    • “Ketamine, an anesthetic commonly used in surgery, is increasingly used to address treatment-resistant depression. In 2019, the FDA approved Spravato, an intranasal spray containing esketamine. In a 2019 trial, 52.5 percent of patients with treatment-resistant depression who took esketamine with an antidepressant for 28 days experienced a significant resolution of their symptoms compared with about 31 percent of people who took an antidepressant with a placebo.” * * *
    • [T]here is unlikely to be one “magic pill” that cures treatment-resistant depression, Dr. Kahn said. People may benefit from a combination of approaches, and they may also need to combine treatments with lifestyle changes.”
  • MedPage Today tells us,
    • “The relationship between physical activity and dementia risk may depend on whether the activity is recreational exercise or job-related labor, a study of more than 4.2 million people suggested.
    • “High physical activity levels were linked to a 20% lower risk of all-cause dementia (relative risk [RR] 0.80, 95% CI 0.75-0.86) over 10 years compared with the lowest level of physical activity, reported Natan Feter, PhD, of the University of Southern California in Los Angeles, and colleagues in a systematic review and meta-analysis.
    • “Leisure-time activities like walking, running, swimming, cycling, or playing sports followed a similar pattern and were tied to lower dementia risk (RR 0.76, 95% CI 0.65-0.88), the researchers wrote in Lancet Public Healthopens in a new tab or window. Household physical activity also appeared beneficial, but evidence was from a single study.”
  • and
    • “A recent report advocated against using BMI as a standalone tool in measuring health risk.
    • “Longitudinal data suggested that high waist circumference was associated with elevated mortality risks, while high BMI was tied to lower mortality risks, among older adults.
    • “Underweight status was associated with a higher mortality risk compared with normal weight in both men and women, regardless of waist circumference.”
  • The American Medical Association lets us know “what doctors want patients to know about mosquito bites.
    • “Mosquito bites spark immune reactions from itchy bumps to Skeeter syndrome and severe illnesses, but prevention and knowing warning signs can reduce risks.”
  • Cardiovascular Business informs us
    • “Transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for severe, symptomatic aortic stenosis. However, surgical aortic valve replacement (SAVR) remains a significantly safer option for patients 60 years old and younger, researchers confirmed in a new study published in JTCVS Open.[1]
    • “Current guidelines recommend SAVR for patients younger than 65 years, yet an increasing number of younger patients are undergoing TAVR with uncertain long-term results,” wrote first author Jessan A. Jishu, MD, with the Tulane University School of Medicine, and colleagues. “Given this lack of clarity and growing real-world adoption of TAVR among younger individuals, this study uses a large-scale database representative of practices in the United States to confirm the findings from these previous studies by assessing short- and long-term outcomes of SAVR versus TAVR in patients younger than 60 years, a population in whom long-term durability and reintervention risk are of particular concern.”
    • “Jishu et al. explored the TriNetX database, exploring real-world data from nearly 10,000 patients who underwent TAVR or SAVR from 2006 to 2025. Approximately 80% of patients were treated with SAVR, but TAVR grew more common from 2020 to the end of the study.”
  • and
    • “A Cedars-Sinai Health Sciences University-led study has identified molecular changes that appear to trigger atherosclerosis years before inflammation, sharing their findings in European Heart Journal.
    • “The group believes this could a key discovery in the development of next-generation early prevention therapies. 
    • “The study’s authors found previously unrecognized molecular pathways and a possible master regulator protein called MLXIPL that could become future targets for clinicians working to stop plaque from ever developing.
    • “We analyzed proteins and gene activity in coronary artery tissue from young adults who died of trauma and had no known coronary artery disease, and we found that more than half already had preclinical atherosclerosis,” first author Sarah Parker, PhD, an associate professor of cardiology and biomedical sciences and co-director of the proteomics and metabolomics core at Cedars-Sinai Health Sciences University, said in a statement. “This suggests that changes in cellular metabolism and communication begin before the inflammation long considered a hallmark of the disease.”
    • “Parker said this research provides a direct picture of what is happening inside the artery wall and may explain why some people are more vulnerable to heart disease than others.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of ifezuntrigene inilparvovec (uniQure N.V.) for Huntington’s disease. This therapy is also known as AMT-130.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in March 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.”  

From the U.S. healthcare business and artificial intelligene front,

  • The Wall Street Journal reports,
    • “Surging healthcare costs are walloping U.S. workers, and they will only worsen next year. For 2027, employers may be facing the biggest health-insurance increase in at least two decades.
    • “Americans with workplace coverage are expected to spend an average $5,297 this year on healthcare, $388 more than 2025, according to a new estimate from benefits-consulting firm Aon. The spending represents a combination of payroll deductions for premiums and out-of-pocket charges like deductibles and copays.
    • “The burden is likely to grow significantly next year, when U.S. employers expect their healthcare costs to go up by 11.1%, according to a new survey from WTW, another big benefits consultant—the steepest rise in more than 20 years.
    • “That would represent the fifth year of escalating increases, according to WTW. “Employers are telling us that this is utterly unsustainable,” said Jeff Levin-Scherz, population-health leader at WTW. Expensive cancer treatments and wide adoption of weight-loss drugs are among the factors pushing up spending.”
  • and
    • “Costco sells its dedicated members everything from travel packages to gasoline. Now the retail giant is gearing up to enter a huge new market: Medicare. 
    • “The warehouse chain plans a limited rollout of Costco-branded Medicare plans, working with SCAN Group, a nonprofit insurer. Nationally, Medicare is a more than $600 billion business for insurers, but the two companies said they would start by selling their jointly named Medicare Advantage products in two states, and a Medicare supplement in a third. 
    • “SCAN and Costco executives said the three target markets include around five million Medicare enrollees but declined to disclose exact locations or timing, citing regulatory limits on disclosure pending approval by the Medicare agency.
    • “SCAN is based in Long Beach, Calif., and Southern California is a core market for the nonprofit, which focuses on Medicare and has about 460,000 members. SCAN also offers Medicare Advantage plans in Arizona, Nevada, New Mexico, Texas and Washington state.”
  • Modern Healthcare adds,
    • “Centene is scaling back its Medicare Advantage presence next year as the health insurance company looks to cut costs. 
    • “The insurer plans to completely withdraw from Oklahoma, Tennessee and Hawaii, according to a notice the company distributed to third-party marketing organizations last week.
    • “Centene is also preparing to exit at least 158 counties and cancel 133 Medicare Advantage plans, according to a Modern Healthcare analysis. Modern Healthcare compared the company’s list of available policies for 2027 to the Centers for Medicare and Medicaid Services enrollment file for this month.
    • “The cancellations would drive about a third of Centene’s Medicare Advantage membership, or more than 340,300 enrollees, to shop for new coverage, according to the Modern Healthcare analysis. Members may have alternative Centene plans from which to choose.” 
       
  • The Health Care Cost Institute released a report about the “Effects of vertical integration on providers’ billing and practice patterns in Medicare (2018-2022)”
  • Fierce Healthcare notes,
    • “The blockbuster success of GLP-1 weight loss drugs has caused major ripple effects across healthcare and pharma, representing a significant growth engine for drugmakers but a cost challenge for payers.
    • “GLP-1s are also potentially disrupting a healthcare system built around treating obesity-related complications, forcing providers, insurers and investors to rethink where future revenue and growth will come from, according to a new report from Wells Fargo.
    • “For decades, the healthcare industry has built service lines, reimbursement models and care pathways around the downstream consequences of obesity. Diabetes clinics, cardiology service lines, sleep medicine, orthopedics, bariatric surgery, pharmacy and chronic disease management have all grown inside a system where obesity was widespread, persistent and often untreated.
    • “GLP-1s may be starting to upend that model as the growing use of obesity drugs begins to influence utilization patterns, hospital economics, pharmaceutical R&D and long-term healthcare spending, wrote Robin Wenzel, head of Wells Fargo Industry Insights and John Teasley, market executive, Wells Fargo Healthcare Banking, in the report.
    • “The latest data from the Centers for Disease Control and Prevention and the National Center for Health Statistics indicates that 40.3% of U.S. adults have obesity, and 9.4%, roughly one in ten, have severe obesity. That makes obesity not an outlier, but a baseline condition around which much of U.S. healthcare now operates, the report authors assert.
    • “GLP-1 drugs for weight management move the management of obesity upstream, to prevention in the context of a system designed around late-stage disease. That puts traditional obesity-related service lines, and healthcare’s obesity revenue engine, under pressure, according to the report.”
  • Beckers Hospital Review points out how 14 large health systems performed financially during the three months ended June 30, and tells us,
    • “New CMS data shows emergency department visit times climbed in the vast majority of states compared with the same period last year, though wide variation persists across the country.
    • “The agency’s “Timely and Effective Care” dataset covers children and adults treated at hospitals paid under the Inpatient Prospective Payment System or Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures. Data was collected in the 12-month period ending Sept. 30, 2025. Learn more about the methodology here.
    • :Nationwide, the median time patients spent in the ED was 162 minutes for the 12-month period ending September 2025, stable from the same period a year prior, according to CMS data.:
  • Healthcare Dive notes,
    • “Name: Dr. Shantanu Nundy
    • “Previous title: Executive vice president of care delivery and chief health officer, Accolade
    • “New title: Chief medical officer, Humana
    • “Nundy will become Humana’s new CMO effective Aug. 31, the Kentucky-based insurer announced Thursday.
    • “He’s replacing Kate Goodrich, who served as CMO from 2022 to October 2025, when she left for a role in the health services division of Humana’s rival insurer UnitedHealth. The CMO post has sat empty since.
    • “As CMO, Nundy will help design Humana’s products, platforms and use of artificial intelligence with a clinical eye, according to the release.”
  • and
    • “Name: Arun Kumar Bhaskara-Baba
    • “Previous title: Chief information officer, Honeywell Aerospace and Defense
    • “New title: Chief information officer, Mayo Clinic
    • “Bhaskara-Baba joined Mayo Clinic as CIO in May, the Minnesota-based health system confirmed in a statement. He’s at the helm of Mayo’s information technology systems across its network of 16 hospitals and 45 multispecialty clinics.
    • “Bhaskara-Baba is succeeding Cris Ross, who retired in 2024 after 12 years in the role.
    • “Bhaskara-Baba brings more than 25 years of tech experience to the role. He joins Mayo from Honeywell Aerospace and Defense, where he directed digital strategy and scaled the company’s artificial intelligence capabilities as CIO.”
  • Fierce Healthcare informs us,
    • “Cityblock Health, a company primarily focused on providing care for urban Medicaid and dual-eligible members, plans to acquire Homeward Health to expand deep into rural markets, the company announced Thursday.
    • “Combined, the two companies will serve nearly 250,000 people and are positioned to reach the 120 million people receiving government-funded healthcare in the U.S., Toyin Ajayi, Cityblock Health CEO and co-founder, wrote in a blog post.
    • “Cityblock said it signed a definitive agreement to acquire Homeward in an all-stock transaction. Financial details of the deal were not disclosed.”
  • and
    • “Carrum Health, a company with value-based Centers of Excellence for employers, is teaming up with Included Health, a virtual care and health navigation company working with employers and plans.
    • “Carrum’s Centers of Excellence network for specialty care will be embedded directly into Included Health’s Alternative Health Plan to help connect members to high-quality specialty care with more predictable costs. The partners will connect plan design, navigation and value-based care into one coordinated experience. 
    • “As employers face steep healthcare cost increases, specialty care often drives a lot of healthcare spending. From 2023 to 2025, the U.S. saw the highest three-year stretch of healthcare cost growth in over a decade, according to the Business Group on Health. The Carrum integration will deliver greater cost predictability with bundled rates, outcomes accountability and streamlined contracting.”
  • Healthcare Dive adds,
    • “Healthcare revenue cycle management company R1 has agreed to acquire Humata Health, a company specializing in artificial intelligence-powered prior authorizations.
    • “R1 is banking that Humata’s AI expertise will help it streamline the preapproval process required by insurers for certain medical treatments, and further its goal of automating how healthcare providers get paid for their services.
    • “The acquisition is expected to close in the third quarter this year, after which Humata’s team will start integrating its technology into R1’s revenue cycle platform. An R1 spokesperson declined to share the financial terms of the deal.”

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The timeline is slipping for senators to strike a bipartisan deal on a short-term funding patch before their August recess as leadership struggles to work out the finer details.
    • “Senior appropriators had been hopeful of unveiling text before the weekend for a stopgap measure expected to keep the government funded into early December. But sources say leaders are now more likely to release text later this weekend or early next week amid snags over a federal grant rule and other add-ons.
    • “The Trump administration’s proposed rule would give senior political appointees greater influence over the grant approval process and has drawn pushback from appropriators on both sides of the aisle.
    • “Senate Appropriations Chair Susan Collins, R-Maine, noted Thursday that the rule has drawn considerable criticism from “a wide range of groups.”
    • “So, I hope we’ll take advantage of this opportunity to delay it,” she said. “But that’s up to the leadership. It’s obviously not a funding issue.”
    • “The grants dispute is among the last-minute hitches and “anomalies” that negotiators have said leadership is sorting through as senators aim for floor consideration next week.
    • “The Senate is currently scheduled to take a procedural vote Monday on the legislative vehicle for the continuing resolution that is needed to stave off a partial government shutdown on Oct. 1, when the new fiscal year begins.
    • “The House has already passed a Republican-crafted stopgap bill to extend current funding through Dec. 4. But senators say further “anomalies,” or deviations from current spending, are needed, noting the gap between add-ons requested by the White House and the House GOP’s bare-bones funding patch.”
  • Bloomberg Law relates,
    • “The Trump administration will increase Medicare payments for hospital services by 2.3%, or $2.1 billion in fiscal year 2027, according to a final rule released Friday.
    • “The final rule (RIN 0938-AV79) from the Centers for Medicare & Medicaid Services also includes a 2.2% reimbursement bump of $54 million for long-term care hospitals, along with several new hospital quality reporting measures.
    • “These include the adoption of quality measures for diabetes, deep vein thrombosis/pulmonary embolisms, quality care planning, and mortality rates. 
    • “The final rule also expands the agency’s Comprehensive Care for Joint Replacement (CJR) Model, which holds hospitals financially accountable for the quality and cost of hip, knee, and ankle replacements, through incentive payments
    • “The agency says the program has produced strong evidence of cost savings while maintaining quality of care. 
    • “The mandatory model will now be expanded nationwide beginning Jan. 1, 2028.”
  • Beckers Hospital Review points out nine things to know about today’s rule.
  • Here’s a link to CMS’s Fact Sheet on today’s rule.
  • The American Hospital Association News adds.
    • “The Centers for Medicare & Medicaid Services today finalized a 2.3% payment update for long-term care hospitals for fiscal year 2027 relative to FY 2026. This includes a 3.2% market basket update, reduced by a 0.9 percentage point productivity adjustment. In addition, CMS finalized its decision to freeze the outlier threshold at $78,936, the same level as FY 2026. For the LTCH Quality Reporting Program, CMS finalized the removal of two measures related to COVID-19 vaccination and a shortened data reporting timeline.
    • :In a statement shared with media today, Joanna Hiatt Kim, AHA’s vice president of payment policy, said, “[W]e remain concerned about continued inadequacies in the LTCH payment system that have contributed to declining patient volumes and the closure of facilities across the country, threatening access to care for medically complex patients. Although the AHA appreciates that CMS did not further raise the outlier threshold in this final rule, broader reforms are needed to support the LTCH field. We remain committed to working with the Administration and Congress to advance the AHA’s LTCH reform principles and promote a more sustainable payment framework that preserves patient access to LTCH services.”
  • The American Hospital Association News further informs us,
    • “The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers to use rebates rather than upfront discounts to effectuate the 340B ceiling price for certain drugs purchased by 340B covered entities. 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The AHA is deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients. The agency’s analysis dramatically understates the true costs of this program, ignoring the hundreds of millions of dollars in compliance expenses, cash-flow disruptions, and operational burdens that will inevitably divert scarce resources away from patient care. At a time when many hospitals are already under severe financial strain, this policy will force hospitals in rural and other underserved communities to spend more on bureaucracy and less on the services and care that patients depend on every day. As we continue to review today’s notice, the AHA is considering all available options to prevent this flawed program from going into effect.” 
    • “HHS’ Health Resources and Services Administration said the pilot is designed to test a rebate-based approach for a set of drugs while gathering information on program integrity, operational impacts and the interaction between the 340B program and Medicare’s Drug Price Negotiation Program. The pilot is limited to drugs included on the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027. 
    • “Under the notice, manufacturers that wish to participate must submit plans to HRSA by Aug. 24. HRSA said it will make approval decisions by Sept. 24, and approved rebate models will take effect Jan. 1, 2027. Participating manufacturers must commit to the pilot for at least one year. “
  • Per an HHS news release,
    • ‘The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $73.2 million in grants to strengthen children’s mental health services, suicide prevention programs, and to expand assisted outpatient treatment (AOT) to those with serious mental illness.”
  • OPM posted in the Federal Register today direct final rules (previously known as interim final rules with opportunity for public comment)
    • FLSA Claims and Compliance
      • to update the provisions concerning Fair Labor Standards Act (FLSA) claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • and
    • Procedures for settling claims
      • to update the provisions concerning administrative claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued governmentwide guidance to departments and agencies on preparing Fiscal Year 2027 Annual Staffing Plans, advancing the Trump Administration’s efforts to modernize federal workforce planning, strengthen merit-based hiring, and ensure agencies are strategically positioned to deliver efficient, high-quality services to the American people.
    • “The guidance implements Executive Order 14356, Ensuring Continued Accountability in Federal Hiring, and provides agencies with a framework for conducting rigorous, bottom-up workforce planning that prioritizes mission-critical positions, modern technology talent, and early career hiring while improving governmentwide visibility into staffing needs.
    • “Annual Staffing Plans will require agencies to identify workforce needs based on mission requirements—not historical staffing levels—and reserve budget and positions for critical hiring priorities, including artificial intelligence, cybersecurity, software engineering, and other technology roles. The guidance also directs agencies to leverage governmentwide hiring initiatives such as US Tech Force and the Early Career Talent Network to improve hiring quality, reduce duplication, and accelerate recruitment across the federal government.”
  • Kevin Moss, writing in Federal News Network, explains “How a household with two federal employees can save on their FEHB premiums by enrolling self-only.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.
    • “The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.”
  • MedTech Dive relates,
    • “Surgical robotics company MMI has received the Food and Drug Administration’s approval to expand an early feasibility study of microsurgery for Alzheimer’s disease.
    • “The REMIND study is evaluating the safety and feasibility of using MMI’s Symani robotic system in microsurgery procedures to re-establish drainage pathways in the deep cervical lymph nodes of patients with neurodegenerative disease. Patients in the trial also have confirmed lymphatic abnormalities.
    • “The FDA gave MMI the go-ahead to expand the number of people who can enroll in the study to 15, from up to five in the initial group, the company said Thursday.”
  • The American Journal of Managed Care lets us know,
    • “Late last week] six peptides received narrow advisory support for potential 503A Bulks List inclusion, an atypical outcome given FDA staff recommendations against all seven under review. 
    • “Legal compounding remains prohibited absent FDA acceptance and completion of proposed and final rulemaking; none of the substances is FDA-approved. 
    • “FDA reviewers cited short, underpowered studies insufficient for safety/efficacy across proposed indications, including limited BPC-157 trial data. 
    • “Committee reconstitution drew conflict-of-interest scrutiny, with increased representation from clinicians and businesses involved in prescribing, producing, or promoting peptides. 
    • “Payers should expect persistent cash-pay utilization and unregulated online procurement, necessitating rigorous medication reconciliation and adverse-event monitoring given sparse human safety data.”

From the judicial front,

  • Per a Justice Department news release,
    • “New York ophthalmology practices Mark D. Fromer, P.C. doing business as Fromer Eye Centers and Floral Park Ophthalmology P.C. have agreed to pay a total of $2.3 million to resolve alleged violations of the False Claims Act arising from their billing for trans-cranial doppler ultrasounds (TCDs) through a kickback arrangement with a third-party testing company. The Estate of Mark Fromer, the former owner of Fromer Eye Centers, also joined in the settlement with the practice. Both practices have agreed to cooperate with the Justice Department’s ongoing investigations of other participants in the alleged scheme.” * * *
    • “The claims resolved by the settlements are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 31, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 53 new US measles cases this week, bringing the total for the year to 2,371 cases.
    • “All but 16 of the cases were locally acquired in 45 US jurisdictions, with the rest tied to international travel, the CDC said in its weekly update. There have been 37 new measles outbreaks reported this year, with 94% of cases associated with outbreaks (defined as three or more cases).” * * *
    • “Among the current measles hotspots is Pennsylvania, which has reported 31 new cases over the past seven days and now has 167 cases for the year, according to the Pennsylvania Department of Health. Officials in neighboring Ohio yesterday confirmed four new cases in unvaccinated individuals in Ashtabula and Tuscarawas counties. It’s Ohio’s third measles outbreak this year.”
  • The American Journal of Managed Care gives us “FAQs: Cyclospora Recovery, Treatment, and Outbreak Prevention Strategies.”
    • “Epidemiologic and traceback evidence implicates shredded iceberg lettuce from Taylor Farms de Mexico as the exposure source, despite a disclosed false-positive border test not changing investigation conclusions. 
    • “Symptom onset typically occurs about one week post-exposure and includes profuse watery diarrhea, anorexia, nausea, bloating, weight loss, and fatigue, while some infections remain asymptomatic. 
    • “Higher-risk groups include immunocompromised patients, older adults, and those with limited care access, who may need longer antibiotic courses and closer monitoring for dehydration and prolonged illness. 
    • “TMP-SMX is the treatment of choice but requires individualized risk–benefit assessment given adverse reactions and a clinically meaningful, though comparatively lower, association with C difficile. 
    • “Public health control relies on clinician/lab case reporting, standardized exposure questionnaires, and FDA traceback; absent whole-genome sequencing for Cyclospora, marker-based genotyping supports source identification.”
  • The Wall Street Journal adds,
    • “In the verdant fields of California’s Salinas Valley, Larry Cox is watching his lettuce wilt.
    • “Cox and his two sons run Coastline Family Farms, which supplies leafy greens to some of the country’s biggest restaurant chains and grocery stores. But this week, in the region known as America’s Salad Bowl, around 300,000 pounds of his romaine hearts were chopped and plowed back into the soil.
    • “There is no evidence that his, or any of the nation’s homegrown lettuce, was infected with the parasite behind an illness outbreak that has sickened thousands of people so far. Even so, that hasn’t stopped Cox’s dependable restaurant and grocery customers from cutting back on orders.
    • “Many growers are destroying the crops they can’t find buyers for. Since lettuce has about a 30-day growing cycle, farmers that are plowing their crops back into the ground are weighing whether to replant or dial back. 
    • “It is incredibly demoralizing,” Cox said. “I would’ve been better off taking a vacation in the South of France than planting the crop.”
  • USA Today relates,
    • “As electric bikes and scooters become an increasingly common way for young people to get around, injuries tied to the devices are climbing at an alarming rate.
    • “New research from Truveta, a health data and analytics firm supported by a coalition of 30 U.S. health systems, analyzed over 12,000 emergency room visits nationwide. The findings revealed that injury rates associated with e-bikes and e-scooters among children and adolescents surged 7.5-fold between January 2023 and May 2026, an increase compared to the rates seen in adults.
    • “ER visits related to e-bikes and e-scooters have increased by 671% for children and adolescents, said Karen Gilbert Farrar, PhD, lead researcher at Truveta. “Just to put that in context, that’s if one patient is was being seen in 2023, that’s now nearly eight patients in 2026.”
    • “The findings also highlight the severity of many crashes: more than one-third of injured patients suffered head or neck injuries. And nearly 7% of child and adolescent visits that were related to e-bike and e-scooter use involved traumatic brain injury, Farrar said.”
  • Health Day lets us know,
    • “E-cigarettes could be reshaping the future of cancer in the United States, by offering people a less-toxic option than smoking, a new study argues.
    • :Smokers are increasingly switching to vaping and other forms of nicotine use, researchers reported July 27 in the journal JNCI Cancer Spectrum.
    • :They’re also sticking with their vapes, rather than swapping back and forth with tobacco cigarettes, researchers found.
    • “Our results show that exclusive cigarette use is being replaced by exclusive use of other combustible products, mainly e-cigarettes, especially among young adults,” said lead researcher Kenneth Michael Cummings, in a news release.”
  • and
    • “Work stress could be eating away at the sleep of most middle-aged working folks, undermining their health, a new study says.
    • “Nearly 70% of a small group of people ages 50 to 66 experienced persistent sleepproblems, even though they had no history of sleep disorders, researchers reported July 28 in the journal Scientific Reports.
    • “Even more concerning, more than 9 out of 10 (92%) of the participants met the clinical threshold for a sleep disorder at least once during the yearlong study, researchers said.
    • “I was genuinely surprised by the sheer scale of sleep problems we uncovered in this otherwise undiagnosed group,” lead researcher Athanasios Tsanas said in a news release. He is a professor of digital health and data science at the University of Edinburgh in the U.K.”
  • BioPharma Dive tells us,
    • “A Novo Nordisk heart drug missed the main goal of a Phase 3 trial, failing to show it prevented heart attacks, strokes or cardiovascular death in people with hardened arteries or chronic kidney disease, the company said Friday.
    • “Called ziltivekimab, the drug is part of a sprawling clinical program involving three late-stage trials that have collectively enrolled more than 20,000 people. Two others, in people with heart failure or who’ve had an acute heart attack, are ongoing. Results are expected next year. They all aim to show lowering levels of an inflammatory protein called IL-6 can can reduce the risk of heart-related complications and death.
    • “Novo gained control of ziltivekimab through a 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million up front and promised up to $2.1 billion in total payouts. Novo said it will take a “non-cash impairment charge” in the third quarter but will not need to change its operating profit forecasts.” 

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Cigna executives offered investors a look at the progress the company has made in the rollout of its new Signature pharmacy benefits model, which moves away from traditional drug rebates.
    • “CEO Brian Evanko said during the company’s earnings call that the team is “making strong progress in the build-out” of the model. It will roll out to Cigna Healthcare’s fully insured plans in 2027, before a wider launch in 2028.
    • ‘In particular, the model is designed around the affordability of brand-name drug products, and the company projects that it could save members 30% per month on branded medications. Through Signature, tech platforms will surface the lowest price to the member at the pharmacy counter, even if that’s a cash-pay option or provided by a manufacturer’s direct-to-consumer programs.
    • “We see significant early interest from health plans and employers as we prepare for our broader market launch in 2028,” Evanko said. “At the same time, we’re adding value and winning business today, with 2027 representing one of our strongest selling seasons in recent years.”
  • and
    • “Alignment Healthcare delivered a strong second quarter, in what CEO John Kao said was supported by the deployment of its new artificial intelligence-powered stratification model.
    • “This advancement improved our ability to predict which members are going to be hospitalized,” Kao said. “Our model now accurately and dynamically predicts the 10% of members who will account for nearly 70% of hospital admissions over the next 30 days.” 
    • “Kao said the on the company’s Thursday earnings call it plans to “reinvest a portion” of savings to areas that produce “tangible, measurable returns,” including market expansions, branding and “deepening AI capabilities.
    • “Beyond its potential to unlock efficiencies in our cost structure, AI represents a meaningful opportunity to further enhance our care model and support providers,” Kao said. “Most importantly, our approach to AI is grounded in decades of clinical expertise and reinforces our commitment to high-quality care. This is further supported by a governance framework to ensure responsible use, human accountability, and equitable treatment of our members.” 
  • Healthcare Dive relates,
    • “Siemens Healthineers has struck a 10-year deal to support diagnostic imaging, cardiology and radiation oncology at Cleveland Clinic, the company said Thursday.
    • “Building on its 35-year relationship with the academic medical center, Siemens Healthineers will provide diagnostic imaging and therapeutic technologies, including magnetic resonance imaging, computed tomography, radiation oncology, interventional radiology and X-ray.
    • “Siemens Healthineers is expanding an existing team dedicated to Cleveland Clinic, adding on-site technicians and training personnel to its current group of more than 30 people.”
  • Beckers Hospital Review points out,
    • “A total of 438 urban hospitals closed across the U.S. between 2000 and June 2026, according to data shared with Becker’s from New Haven, Conn.-based Yale University’s Health Care Affordability Lab.
    • “Between 2001 and 2023, the period for which both openings and closures are fully tracked, urban hospitals posted a net gain of 11 nationally, with 396 openings and 385 closures. However, there were significant losses in individual states. New York lost a net 33 urban hospitals over that period, California lost 29 and Pennsylvania lost 24.
    • “The data covers general, short-term acute-care hospitals and excludes specialty facilities such as psychiatric, rehabilitation, children’s and VA hospitals. Urban and rural classifications follow the census-tract-level definition from the Health Resources & Services Administration’s Federal Office of Rural Health Policy.
    • “The tables [found in the article] show urban hospital net change by state from 2001 to 2023 and total urban closures by state from 2000 through June 2026. States with no urban hospital activity in the Yale dataset are not listed.
  • Fierce Pharma informs us,
    • “The small inflection point we noticed two weeks ago regarding Eli Lilly’s Foundayo does not appear to be a flash in the pan. Weekly total prescriptions for the small molecule reached 29,388, a new high for the oral GLP-1 receptor agonist after three weeks of consecutive growth, according to IQVIA data cited by Citi. 
    • “As IQVIA may be missing some scripts from telehealth channels, we will get a clearer picture of Foundayo’s launch progress when Lilly reports its second-quarter earnings on Wednesday, Aug. 5. Analysts at Jefferies have been modeling $71 million in U.S. sales for the quarter based on IQVIA data.
    • “Meanwhile, Novo Nordisk’s Wegovy pill remains far ahead in the oral GLP-1 race with total scripts also hitting a new record of about 171,700, according to Citi. The number represents 1.1% growth from its previous best recorded during the prior week.
    • “Coincidentally, the entire GLP-1 class also saw its total scripts grow 1.1% sequentially across diabetes and obesity uses. Lilly’s Zepbound regained some lost ground with total scripts up 1.9% week over week. That’s compared to Wegovy, which now makes up 40.6% of the obesity market after a 0.2% sequential decline in total scripts.” 
  • Per Fierce Healthcare,
    • “WellSpan Health inked an expanded multi-year partnership with artificial intelligence company Hippocratic AI, which expands AI-powered capacity across the network.
    • “Through the update, Hippocratic AI’s generative AI agent—Ana—will expand from handling inbound calls and primary care appointment scheduling to post-discharge follow-up and chronic disease check-ins.
    • “Initial workflows will focus on closing care gaps through outreach to patients with missed imaging appointments, executives say. Every new use of the AI agent will follow governance, safety and implementation structures in coordination with WellSpan teams.
    • “WellSpan Health CEO Roxanna Gapstur, Ph.D, said in a statement the future of the industry will “be shaped by the organizations that build the culture, governance and clinical capabilities” to utilize AI responsibly at scale.
    • “At WellSpan, we’ve been intentional about creating this foundation, so innovation advances safely, strengthens clinical excellence and earns trust,” Gapstur said. “Our expanded partnership with Hippocratic AI is an investment in the future of care — one that expands access, supports our care teams and creates a more personalized experience for every patient we serve.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services fact sheets
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates for Inpatient Psychiatric Facilities (IPFs) under the IPF Prospective Payment System (PPS) (CMS-1847-F) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with its statutory authority to update Medicare payment policies for IPFs annually. 
    • “This fact sheet discusses the provisions of the final rule, including annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis. In addition, the rule finalizes a policy effective for FY 2028 (October 1, 2027) to limit outlier payments at the facility level to no more than 20% of an IPF’s total IPF PPS payments in a year, for IPFs with at least 50 stays per year. For the IPF Quality Reporting Program, CMS is removing two measures from the program, as well as implementing a standardized IPF patient assessment instrument.
    • “For FY 2027, CMS is updating the IPF PPS payment rates by 2.3%, based on the 2021-based IPF market basket increase of 3.2% less a 0.9 percentage point productivity adjustment. Additionally, CMS is updating the outlier threshold so that estimated outlier payments remain at 2% of total IPF PPS payments. Total estimated payments to IPFs would increase by 2.3%, or $60 million, in FY 2027, relative to IPF payments in FY 2026.”
  • and 
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for updates to Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with the legal requirements to update Medicare payment policies for SNFs annually. This fact sheet discusses the final rule’s provisions.
    • “For FY 2027, CMS finalized updating SNF PPS rates by 2.4% based on the final SNF market basket of 3.3%, reduced by a 0.9% productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs.”
  • Beckers Hospital Review points out twelve things to know about these rules.
  • The American Hospital Association News relates,
    • “The Health and Human Services Secretary today announced that dozens of insurers, medical societies, healthcare providers and behavioral health experts have pledged to strengthen the nation’s behavioral health system by advancing best practices aimed at improving mental health and addiction treatment. The pledge commits participants to promoting timely access, improving quality measurement and accountability, supporting patient-centered recovery services and expanding whole-person treatment that addresses behavioral and physical health needs. HHS said the initiative aligns with the administration’s broader efforts to address addiction and mental illness and improve long-term patient outcomes.” 
  • Federal News Network clears up common misconceptions about federal retirement benefits.
    • “Misconception: Federal Employee Health Benefits (FEHB) go away at retirement, or become more expensive.
    • “Fact: Under certain eligibility requirements, federal employees can continue their FEHB coverage into retirement. These requirements include enrollment in FEHB for at least five consecutive years leading up to, and having coverage on, the retirement date. It is important to note that qualified spouses, dependent children, and children with disabilities can be covered without meeting this five-year rule. Employees become classified as annuitants upon retiring, at which point the government will continue to cover about 72% of the FEHB premium.
    • In addition, retirees can also enroll in Medicare parts A and B, offering nearly comprehensive coverage, with Medicare as the primary payer and FEHB as secondary. To reduce costs, some retirees opt for a basic FEHB plan.”
    • “Misconception: Spouses will automatically continue to be covered by FEHB into retirement
    • “Fact: This is the biggest caveat about survivor’s benefits: If survivors were on the federal retiree’s health insurance plan, that health insurance will cease if there is no survivor’s benefit. Any amount of survivor’s benefit will continue the health insurance plan, so prospective retirees and their spouses should speak with a federal retirement consultant, and consider the holistic picture of their assets, the spouse’s income, their needs and budget, life insurance, and whether they have any additional financial obligations, like debt or a child in college.”
    • “Misconception: Survivor’s benefits are automatic and free
    • “Fact: Federal employees will need to make some decisions about survivor’s benefits on their retirement application. The pension is the main place where retirees need to consider their options along with their potential beneficiaries — these will primarily be spouses, except in a few special circumstances. Each of these options comes with a cost, in the form of a monthly percentage deducted from the overall pension. The options and percentages vary between the Federal Employees Retirement System and the Civil Service Retirement System.”
  • Beckers Hospital Review tells us,
    • “Federal policy changes could reshape pharmacy reimbursement, drug pricing and hospital operations in 2027, according to a new Vizient outlook. The report, published July 27, highlights four pharmacy developments health systems should monitor as they plan for the year ahead.
    • “The four policy developments:
      • “340B outpatient drug reimbursement: CMS has proposed reducing reimbursement for 340B-acquired drugs from average sales price plus 6% to ASP-33.4%. 
      • “340B remedy offset: CMS has proposed increasing the offset from -0.5% to -3%, a change the agency estimates would reduce payments by $2.3 billion in 2027.
      • “Section 232 tariffs: New pharmaceutical tariffs and ongoing investigations into medical devices could affect supply chains and costs.
      • “Medicare Drug Price Negotiation Program: CMS has issued draft guidance for implementing negotiated prices in 2028, including drugs covered under Medicare Parts B and D.

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
    • “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
    • “Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.”
  • Contemporary OB/GYN relates,
    • “On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.1
    • “The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).2 Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.” * * *
    • “Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.”
  • and
    • “Natural Cycles has received its sixth FDA clearance, this time for an updated version of the algorithm underlying its FDA-cleared birth control app. The company described the update as combining statistical modeling with machine learning trained on real-world fertility data to generate more individualized fertility predictions for users, according to a news release published July 27, 2026.”
  • Cancer Network tells us,
    • “The FDA has granted fast track designation to ISM6331, an AI-designed pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti–PD-1 antibody therapy, with or without anti–CTLA-4 antibody therapy, and platinum-based chemotherapy, according to a news release from the developer, Insilico Medicine.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantity coronary inflammation from routine coronary CT angiography (CCTA). 
    • “The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
    • “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women’s and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the U.S.”
  • STAT News informs us.
    • “A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  
    • “The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 
    • “The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 
    • “The negative vote came at the end of an all-day meeting during which disputed results from a Phase 3 clinical trial were discussed and debated. Capricor’s presentation highlighted an analysis showing deramiocel preserved upper-arm function and staved off the heart failure most patients with Duchenne eventually experience.
    • “The FDA countered with a critique of the data that reached opposite conclusions — deramiocel was unable to separate from placebo at all. The agency also spent a good deal of time during Wednesday’s meeting calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.” 
  • Beckers Hospital Review notes,
    • “The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.” * * *
    • “The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
    • “The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 12,000 pounds of smoked bacon imported from Canada were recalled because of lack of proper reinspection before entering the country, the Agriculture Department’s Food Safety and Inspection Service said.
    • “The bacon from Maple Leaf Foods was shipped to grocery distributors and retailers in Idaho, Oregon and Washington state. FSIS inspects imported products for packaging, documentation, condition and contamination.” * * *
    • “There are currently no confirmed cases of illness or injuries due to the products, FSIS said.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention yesterday reported 18,207 confirmed or suspected cases of cyclosporiasis across the U.S. from the current outbreak. The agency said it is investigating multiple case clusters, including an outbreak impacting nine states that is linked to iceberg lettuce. A July 17 Food and Drug Administration notice said that Taylor Farms recalled iceberg lettuce sourced from central Mexico that was distributed to 27 states, due to the potential of being contaminated with cyclospora.” 
  • The New York Times lets us know about “Nine Things Experts Wish You’d Do in Midlife to Increase Longevity.”
    • “How you treat your body and brain in your midlife years, loosely defined as 40 to 60, can hugely influence how you age in the decades to come.
    • “The seeds for many age-related diseases, including cardiovascular disease, diabetes, cancer and dementia, are sown in middle age, so it’s important to start thinking about prevention early. And it takes a lifetime of healthy habits, not just a few weeks, to move the needle on your longevity.
    • “Midlife is the ideal time to make changes, not only to benefit you in the present, but also in the future,” said Margie Lachman, a psychology professor at Brandeis University and the author of “Primetime: A New Vision for Midlife.”
    • “After all, she added, “What happens in midlife doesn’t stay in midlife.”
    • “We spoke with experts about some small habits that can make a big difference.”
  • Health Day tells us,
    • “Childhood obesity can be effectively treated through a family-based program provided through their local pediatrician, a new clinical trial says.
    • “About 42% of kids in the program lost enough weight to improve their heart health and lower their diabetes risk within a year and a half, researchers reported July 27 in JAMA Pediatrics.
    • “The program teaches families how to establish healthy eating and exercise habits, including positive reinforcement and supportive routines, researchers said.
    • “Our results show that an established, effective obesity treatment for children and adolescents can be successfully delivered in their pediatrician’s office,” lead researcher Amanda Staiano said in a news release. She is director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical Research Center at Louisiana State University.”
  • Drug Topics informs us,
    • “Alcohol use, binge drinking, and heavy drinking have all increased significantly among pregnant women in the US from 2011 to 2024, according to a JAMA study. Likewise, with no end in sight for the trends in their findings, study authors consider them “concerning,” highlighting the need to address the growing trends among expecting mothers and their alcohol consumption.
    • “It is well established that alcohol is a teratogen, and numerous existing guidelines advise women to abstain from alcohol during pregnancy and while breastfeeding,” wrote the authors of a study in Drug and Alcohol Review. “However, many women consume alcohol in pregnancy even after learning they are pregnant. Worldwide, approximately 10% of women in the general population consume alcohol in pregnancy, although the European region has the highest rate of consumption (25%).
    • “The JAMA analysis revealed that from 2011 to 2024, the relative increase in current alcohol use among pregnant individuals reached 59%, and binge drinking rose by 77% and heavy drinking surged by a startling 166%. These absolute increases, 5.4%, 2%, and 1.2%, respectively, represent a significant shift in behavior that researchers indicate has no clear sign of reversal.”
  • Genetic Engineering and BioTechnology New lets us know,
    • “Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
    • “The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
    • “The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On August 5, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.”
  • Per STAT News,
    • “For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.
    • “The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.” * * *
    • “The biotech plans to start a Phase 3 study later this year of patients who’ve had bunion removal surgery, with results expected in the second half of 2027.”

From the U.S. healthcare business and articifical intelligence fronts,

  • Beckers Payer Issues reports,
    • “Humana reported a $694 million profit for the second quarter, up more than 27% year over year, according to its July 29 earnings report.
    • “Revenue reached $40.8 billion, a 26% increase from the same period in 2025, driven by Medicare membership growth, higher per-member Medicare Advantage and standalone prescription drug plan premiums from increases in benchmark funding and the Part D direct subsidy, and a payer-agnostic CenterWell client base. Star ratings headwinds persisted.
    • “Total Medicare membership reached 11.1 million, up from 8.2 million in the comparable quarter. Total medical membership was 17.9 million, an increase from 14.8 million.
    • “The company’s benefit ratio was 91.1%, up from 89.7% in the second quarter of 2025, spurred by the star ratings revenue issue, new individual MA members with higher benefit ratios and an expectation of lower favorable prior period development. However, MA recontracting, pricing and clinical excellence efforts offset that growth.”
  • Beckers Hospital Review notes,
    • “Jaewon Ryu, MD, the founding CEO of Risant Health, will step down, and Dale Maxwell has been named interim CEO.
    • “According to a July 29 news release, Dr. Ryu made the decision to leave the role to focus on his family. Mr. Maxwell, former president and CEO of Albuquerque, N.M.-based Presbyterian Healthcare Services, will serve as interim CEO while the Risant Health board conducts a national search for a permanent successor.
    • “Washington, D.C.-based Risant Health is a nonprofit created by Oakland, Calif.-based Kaiser Permanente to expand value-based care by partnering with community health systems. As the organization’s inaugural CEO, Dr. Ryu built its leadership team and operating model and oversaw the additions of Danville, Pa.-based Geisinger, which operates 10 hospital campuses, and Greensboro, N.C.-based Cone Health, which has five hospitals and more than 150 locations.
    • “Jaewon has been instrumental in turning the vision for Risant Health into reality,” Greg Adams, chair and CEO of Kaiser Permanente and chair of the Risant Health board, said in the release. Mr. Adams said Dr. Ryu built an exceptional leadership team and positioned the organization to expand value-based care.”
  • Fierce Healthcare relates,
    • “AI doctor startup Doctronic aims to broaden its reach beyond adult primary care by acquiring text-based pediatric care platform Summer Health.
    • “The companies did not disclose the financial terms of the deal.
    • “Fast-growing Doctronic is an AI-native primary care provider that has supported 30 million health encounters in just two years. It offers a proprietary AI doctor and nationwide network of licensed clinicians delivering personalized medical guidance and video visits for $39, according to the company.
    • “The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”
  • and
    • “Hospitals should plan for their supply chain expenses to climb in 2027, with the prices for indirect spending categories like IT, construction and even food projected to grow at an even faster rate than those for drugs, Vizient warned in its most recent forecast report. 
    • “Vizient’s latest twice-yearly report mapped out overall supply chain price inflation of 3.39% for 2027, an increase of 0.61 percentage points compared to the forecast it released in February for the 12-month period beginning in H2 2026. 
    • “The primary culprits, Vizient research and intelligence director Jeff King told Fierce Healthcare, are AI demand and elevated costs of logistics and energy that are being felt across the world.”
  • and
    • “Alongside an update to its 2026 ratings, national nonprofit Leapfrog Group announced Monday the launch of an expanded ambulatory service center (ASC) reporting program. The expanded Leapfrog ASC Public Reporting Program, first unveiled in April, reports safety and quality information for facilities nationwide. More than 3,900 ASCs are now included in the 2026 ratings, along with more than 2,400 hospitals—which the nonprofit says is the highest level of participation in its 26-year history.”
  • Fierce Pharma points out,
    • “With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis (MS) portfolio, Biogen is once again positioned for a “growth story,” CEO Chris Viehbacher said Wednesday during the company’s second-quarter earnings call.
    • “To that end, Biogen reported revenue of $2.74 billion for the period, marking its highest quarterly haul since Q3 of 2021. With the result, the company flipped its 2026 revenue guidance from an expected mid-single digit decline in 2026 to a mid-single digit increase.  
    • “This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth,” Viehbacher added.
  • Beckers Hospital Review tells us what 17 pharmacy leaders think about “the biggest shifts they’re seeing in patient expectations.”
  • MedCity News informs us,
    • “For many people, managing a disease means chronic therapy. Scribe Therapeutics has a different vision: genetic medicines that offer durable effects for the masses. With its lead program on a path to report its first human data next year, Scribe has joined the public markets, raising $128.7 million. 
    • “While current genetic medicines are largely limited to rare disorders, we are engineering our technologies for use in common diseases affecting millions,” Scribe said in its IPO filing. “By targeting prevalent diseases with significant unmet need and high clinical burden, we aim to usher in a new era of broadly scalable, transformative, and preventative genetic medicines.”
    • * * * “Alameda, California-based Scribe has selected cardiometabolic disorders as its first focus. Lead therapeutic candidate STX-1150 is intended to lower the “bad” form of cholesterol, which is a risk factor for atherosclerotic cardiovascular disease (ASCVD). This therapy is designed to lower LDL-cholesterol by repressing expression of PCSK9, a protein that in high amounts, reduces the ability of the liver to clear cholesterol from the blood. Injectable PCSK9 inhibitors are already available from Amgen, Regeneron Pharmaceuticals, and Novartis. Last week, Merck received FDA approval for Lipfendra, an oral PCSK9 inhibitor. While dosing frequency for these therapies varies, all of them are taken chronically.”
  • STAT News reports,
    • “Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 
    • “Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 
    • “The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.” * * *
    • “Scientists acknowledge that no one test will ever tell the whole story about clinical AI performance. And day-to-day, the choice of when and how to use large language models in care — by individual doctors, and increasingly health system leaders — is shaped by more than research.
    • “I don’t see the benchmarks really playing a role among doctors,” said OpenEvidence’s Nadler. “Academics like talking about them.” 
    • “The more important question, companies, doctors, and researchers agree, is how these tools impact patients. 
    • “Anytime a new technology is introduced into medicine, its impact on those outcomes depends on how it’s used by physicians. Are they using the tool safely and correctly, on the right patients, in the right situations?
    • “In the case of AI, that often comes down to trust. An accurate model inspires confidence, but it can still occasionally be wrong — potentially leading a physician astray, if they rely on it outright. Conversely, a good model can leave gains on the table if a physician doesn’t trust its output.” 


Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Centers for Medicare and Medicaid Service news release,
    • “On July 28, 2026, the Centers for Medicare & Medicaid Services (CMS) released preliminary technical Medicare Part D bid information for contract year (CY) 2027 to help Part D plan sponsors finalize their Part D and Medicare Advantage (MA) offerings and prepare for Medicare Open Enrollment. 
    • “Additionally, CMS is announcing the conclusion of the Part D Premium Stabilization Demonstration, a voluntary demonstration for standalone prescription drug plans implemented in CY 2025 to address volatility and variation in standalone premiums following benefit changes mandated by the Inflation Reduction Act (IRA). For CY 2027, CMS bid analysis indicates that Part D plan sponsors had sufficient experience under the redesigned Part D benefit to support their assumptions in developing the prescription drug plan bids. Therefore, CMS will discontinue the demonstration at the end of CY 2026 to return the program to operating under traditional market conditions in CY 2027. 
    • “As in past years, CMS will release the 2027 MA and Part D landscape in mid-to-late September, once all offerings are finalized. In addition, CMS will release final average MA and Part D premiums, along with other key information, in September with the MA and Part D landscape.” 
  • The Wall Street Journal adds,
    • “The average premium for a Part D plan was around $36 a month this year, according to KFF, a health-policy nonprofit. 
    • “The administration official said around 25% of Medicare Part D plan enrollees would see premiums for their plans stay flat or go down next year. Around 30% will have an increase of less than $10 to their monthly bill. 
    • “For the remaining 45%, he said, the increases are largely in the $11 to $20 range a month. 
    • “Seniors should be able to find lower premiums if they switch plans, he said, adding affordable options are still available.
    • “Medicare drug coverage premiums are rising because the plans have been hit by growing expenses for GLP-1 medications and other specialty drugs. Changes implemented under 2022’s Inflation Reduction Act also have pushed up premiums. The law reduced many Medicare enrollees’ out-of-pocket expenses but required insurers to shoulder more of the costs. 
    • “Those pressures are expected to continue in 2027, said Juliette Cubanski, a vice president at KFF.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services July 27 released its Contract Year 2025 Part C and Part D Program Audit and Enforcement Report, outlining key compliance issues identified through Medicare Advantage and Part D audits and enforcement activities. CMS emphasized recurring problems involving prior authorization and appeals processing, beneficiary access to medications and services, care coordination, enrollment and eligibility errors, and oversight of delegated entities. The report also highlights enforcement actions totaling approximately $1.54 million in civil money penalties, most of which stemmed from beneficiary cost-sharing and payment integrity failures. CMS signaled increased scrutiny of plans’ compliance with new prior authorization requirements, including the requirement beginning this year to process expedited requests within 72 hours and standard requests within seven calendar days.” 
  • A CMS news release adds,
    • “The Centers for Medicare & Medicaid Services (CMS) announced that enforcement efforts from its Medicaid Fraud War Room (MFWR) stopped more than $203 million in potentially improper Medicaid payments in just under 90 days, highlighting significant progress in protecting taxpayer dollars and strengthening Medicaid program integrity. Since its launch on April 23, the MFWR has coordinated actions against 50 unique, high-risk Medicaid providers identified through advanced data analytics and representing more than $203 million in Medicaid payments subject to federal exclusions and state enforcement efforts.
    • “Every dollar lost to Medicaid fraud is a dollar taken away from vulnerable Americans who rely on it,” said CMS Administrator Dr. Mehmet Oz. “In just under 90 days, the Medicaid Fraud War Room has proved that these losses aren’t inevitable and has shown Americans what we can accomplish with robust federal-state partnerships, advanced data analytics, and a real sense of urgency. We’ve made significant progress toward crushing waste, fraud, and abuse, but we’re not done yet. If you steal from Medicaid, we will track you down, cut you off, and work to ensure that every taxpayer dollar we spend funds quality care for eligible beneficiaries.”
  • The American Hospital Association News further tells us,
    • “An AHA blog published July 28 highlights new electronic prior authorization requirements that begin Jan. 1, 2027, as a result of the Centers for Medicare & Medicaid Services’ 2024 Interoperability and Prior Authorization final rule. The blog explains why transitioning to the new process will be a significant operational change that will include coordination with health plans, electronic health record vendors and other technology partners. READ MORE“
  • Per a CMS notice to be published tomorrow in the Federal Register,
    • In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Office of Personnel Management, “ Verification of Eligibility for Minimum Essential Coverage Under the
    • Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan”. The matching program provides CMS and State Administering Entities with the Office of Personnel Management (OPM) data to use in determining individuals’ eligibility to enroll in a qualified health plan through an exchange established under the ACA; for insurance affordability programs, certifications of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Even as the number of cyclospora cases in the United States hit record levels, top health regulators insisted that consumers could still trust what they were eating.
    • “The U.S. food supply is safe,” Donald Prater, the acting deputy commissioner for food at the U.S. Food and Drug Administration, told attendees Monday at the annual meeting of the International Association for Food Protection.
    • “However, there’s a couple of challenges,” he said, referring to the cyclosporiasis outbreaks that have sickened more than 11,000 people across the country. “It will take a little time. But we do believe we’re taking action and we’re protecting public health.”
  • The Hill adds,
    • “A poll released Sunday shows that 40 percent of U.S. adults are buying or eating less produce after the cyclospora outbreak. 
    • “Comparatively, according to survey results from CBS/YouGov, 4 percent of people said they are eating more produce. 
    • “Among respondents, 56 percent said there has been no change in their diet.” 
  • Fierce Pharma relates,
    • “The FDA has signed off on MannKind’s Furoscix ReadyFlow (furosemide) autoinjector for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD).
    • “Furoscix ReadyFlow becomes the first at-home treatment option to reduce the fluid buildup from HF or CKD. The drug-device combo has been designed to help patients address edema earlier, before symptoms worsen and lead to potential emergency department visits or hospitalization. It has been shown to work as effectively as an intravenous diuretic, which is usually administered in a clinic or hospital.
    • “Furoscix ReadyFlow is taken under the skin in less than 10 seconds, significantly reducing the administration time from five hours with MannKind’s currently available on-body infusor. The company expects to make Furoscix available in the U.S. by the end of August.”
  • The ASCO Post informs us,
    • “The FDA’s Oncology Center of Excellence announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.  
    • “Fewer than 5% of patients with cancer currently receiving treatment are enrolled in clinical trials—even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation: stringent and complex clinical trial eligibility criteria. 
    • “Unnecessarily restrictive eligibility criteria may slow subject accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug,” the three guidances say in their preambles.”  
  • The American Hospital Association News points out,
    • “Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according to a Food and Drug Administration notice. The company is recalling lot LD175708 of its Cefazolin in Dextrose Injection with an expiration date of Feb. 14, 2027. Baxter said use of the product can potentially cause pulmonary embolism, among other harmful impacts. The company said that customers should immediately discontinue use of the solution and return all affected products. Baxter has not received any reports of adverse events related to the issue.” 
  • Cardiovascular Business adds,
    • “Medtronic is recalling specific lots of six different medical devices used as arterial cannulae during cardiopulmonary bypass procedures. This includes multiple models of the company’s 22FR EOPA 3D Arterial Cannulae and its 22FR EOPA Elongated One-Piece Arterial Cannulae.  
    • “Medtronic initiated the new recall after receiving more than 30 reports of small pinhole leaks in the wire-wound body of the devices. These leaks can be difficult to identify during routine inspection; they are primarily visible when the cannula is in a flexed position. 
    • “Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia and organ dysfunction,” according to an alert shared with customers.” 

No Surprises Act News,

  • Elevance Health, writing in STAT News, reports
    • The [Elevance Health] analysis [of No Surprises Act arbitrations] examined more than 7,300 disputed claim lines involving spine surgery, plastic surgery, colonoscopies, hysteroscopies, and other planned procedures resolved between 2024 and early 2026. Across the procedures studied, providers prevailed in nearly 90% of disputes, and the average award approached $40,000 per disputed claim line.
    • The arbitration awards were also found to be drastically higher than commonly used payment benchmarks. Across the planned procedures analyzed, the median award was more than 50 times the qualifying payment amount, which is the benchmark based on an insurer’s median in-network contracted rate. Worse still, the median arbitration award was 29 times higher than median in-network commercial claims, and 67 times higher than Medicare rates for the same procedures in the same locations. Awards for assistant surgeons were even more extreme, with the median award more than 145 times the qualifying payment amount.
    • Researchers also found that awards for these planned procedures increased over time. Between 2024 and 2025, arbitration awards for the procedures analyzed rose by 43%.
    • Although these disputes represented a relatively small share of overall IDR volume, they accounted for a disproportionate share of arbitration costs because of the size of the awards. Planned surgical procedures and associated neuromonitoring represented roughly 16% of disputes but approximately 60% of No Surprises Act arbitration costs.” * * *
    • “The findings do not describe all No Surprises Act disputes. They focus on a defined subset of planned procedures and associated services. But they point to a broader implementation question: whether some categories of scheduled services are entering IDR in ways that could increase costs.
    • “The study identifies several policy considerations for policymakers to evaluate, including strengthening eligibility standards for planned procedures entering IDR, increasing transparency around arbitration decisions, reinforcing the use of market-based payment benchmarks, and providing additional guidance for arbitrators evaluating payment disputes.”
  • FEHBlog observation: Amen to that. Those changes would lower healthcare costs.

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Kira Wynn will do almost anything to avoid ovarian cancer, which killed her mother.”
    • * * * “So Ms. Wynn, 37, had a consultation with Dr. Rebecca Stone, a gynecological oncologist at Johns Hopkins Medicine. What she heard was not what she expected.
    • “Ovarian cancer,” Dr. Stone told her, is a misnomer. Nearly all ovarian cancers — and nearly all fatal ovarian cancers — are actually cancers of the fallopian tubes. The 20 percent or so that start in the ovaries are different, Dr. Stone said, and usually can be cured.
    • “Women who have their tubes — the gummy worm-shaped ducts that carry eggs from the ovaries to the uterus — removed reduce their chances of getting ovarian cancer by nearly 80 percent. It’s a five-minute operation that can be done as part of nearly any abdominal surgery, including a hysterectomy, tubal ligation, gallbladder surgery and hernia repair.
    • “Yet no doctor, Ms. Wynn said, had ever mentioned fallopian tube removal to her.
    • “That’s not surprising, Dr. Stone said, because most doctors (and the public) do not know about this new approach, even though professional groups like the American Cancer Society, the American College of Surgeons and the European Society of Gynaecological Oncology have recently issued statements encouraging doctors to offer tube removal at the time of other abdominal surgeries.”
  • The American Hospital Association relates,
    • “The American Red Cross July 27 declared a national blood supply crisis, as the organization said that blood donations have fallen to a four-year summer low. The organization said that it has less than a one-day national supply of type O positive blood and is limiting distribution of type O blood to hospitals. This year is the second time in its history that the Red Cross declared a national blood crisis, the first since January 2022.” 
  • The Washington Post adds,
    • “The American Red Cross has less than a one-day national supply of O-positive blood, the most commonly transfused blood type, and has begun limiting distributions of the blood to hospitals, it said.
    • “The only previous national blood crisis declared by the group came in 2022 as a surge of covid-19 cases lowered blood donor turnout.
    • “The American Red Cross urged all eligible donors to make appointments to give blood.”
  • Health Day tells us,
    • “Middle-aged folks have a higher risk of muscle loss if their weight “yo-yos” due to inconsistent dieting, a new study says.
    • “People who repeatedly dropped and regained weight wound up losing nearly four times as much thigh muscle during a four-year period compared to others whose weight remained relatively steady, researchers recently reported in the journal Radiology.
    • “When people’s weight cycled, they lost tremendous amounts of muscle along with the fat, and they didn’t gain the muscle back,” said lead researcher Dr. Thomas Link, a professor of radiology at the University of California-San Francisco.
    • “This tells us that understanding how to protect muscle while people are losing weight is important for overall health,” he said in a news release.”
  • The Washington Post adds,
    • “Savings to the overall health care economy from GLP-1 drugs have yet to be proven, but researchers have found evidence that health benefits could spill into the labor market.
    • “A study of workers in Denmark showed a 17.3 percent decline in long-term sick leave among those who were treated with Ozempic, the diabetes drug, according to results published this month in a National Bureau of Economic Research working paper. The researchers were from the University of Copenhagen, the University of Chicago, Duke University and the Rockwool Foundation — an independent organization that conducts research on social and economic issues.
    • “Before treatment, the study noted, an average of 5.5 percent of the workers accessed long-term sick leave (defined as longer than 30 days). That dropped nearly a full percentage point after treatment with the drug, the research found. About 84 percent of the patients in the study, which was conducted through analysis of health records and has not been peer-reviewed, had diabetes.”
  • MedPage Today points out,
    • “Nongated chest CT scans are usually performed for reasons other than to assess cardiovascular risk.
    • “Incidental coronary artery calcium (CAC) scores extracted from nongated chest CT scans accurately predicted cardiovascular risks in a community-based cohort.
    • “Patients with moderate or severe nongated CAC had significantly higher risks of cardiovascular disease and coronary heart disease versus those with zero CAC.”
  • STAT News notes,
    • “An interim look at an Alzheimer’s disease clinical trial evaluating an amyloid-targeting treatment from ProMIS Neurosciences showed low rates of brain bleeding and no incidences of brain swelling — results reported Tuesday that suggest the drug could be safer than approved treatments. 
    • “In a blinded analysis that pooled safety data from patients receiving the ProMIS drug and a placebo, the total rate of ARIA was 4.4%, with all cases mild and asymptomatic, the company said.” * * *
    • “ProMIS expects all the participants in the Phase 1 study to complete twelve months of treatment late this year, allowing the company to unblind the data and report full results, including measures of cognition and function, early in 2027.” 
  • Genetic Engineering and Biotechnology News adds,
    • “Neurodegenerative diseases are typically defined by the presence of characteristic clinical phenotypes. However, it is increasingly recognized that early intervention could give people the best chance for meaningful positive effects. As a result, early detection and prevention are becoming major priorities.
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “In this study, researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS.
    • “This work is published in Nature Medicine in the paper, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS.”
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “ICER examined the impact of Covid-19 vaccines and found that pregnant women, infants, and adults aged 65+ benefit most from vaccination. ICER’s report on this therapy was the subject of the June 2026 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. The New England CEPAC was aligned with ICER’s report findings.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
    • “The current confusion in the US around vaccine policy is challenging for both health care professionals and the American public,” said ICER’s President and CEO Sarah K. Emond, MPP. “Policymakers, especially public health leaders, need reliable and unbiased assessments of how well therapies work for patients. For 20 years, ICER has delivered that through our evidence-based analyses and public meetings. This public meeting highlighted what we know about the current evidence on Covid-19 vaccines, and where there are opportunities to gain an even better understanding of how these vaccinations impact different subpopulations. Ultimately, ICER’s transparent and public process sheds light on the broader context that policymakers should consider when making recommendations about Covid-19 vaccines.”

From the U.S. healthcare business and artificial intelligence fronts,

  • MedCity News reports,
    • “It’s often said that the healthcare system is broken, from the outdated use of fax machines to perverse incentives.
    • “But who broke the healthcare system? At MedCity News’ Bullseye event in Chicago, Editor-in-Chief Arundhati Parmar posed this question to two health insurance CEOs.
    • “The response? “We did,” replied Sachin Jain, CEO of SCAN Health Plan, referring to all of those who work inside of healthcare. He added that healthcare stakeholders have normalized the abnormal.” * * *
    • “The CEO of Ascendiun, Paul Markovich, echoed this. Ascendiun is a nonprofit and parent company of Blue Shield of California, Blue Shield Promise Health Plan, Altais and Stellarus.
    • “It’s our own damn fault collectively, and I think that’s why we’re trying to focus a lot of our energy on the system. … One of the reasons I work at a health plan and a nonprofit health plan is because I think what the health plans can do is create a better system,” he said. “We tend to control the rules of how people get paid, what are the administrative burdens? Are we using a fax machine, or are we figuring out another way to connect digitally? We have the biggest influence, I think, in trying to shift the system to getting much better results from people day to day than what we’re seeing now.”
  • Healthcare Dive relates,
    • “Centene handily beat Wall Street’s expectations in the second quarter, as higher revenue from premiums and rate hikes for the managed care company’s plans shielded its bottom line from elevated medical costs.
    • “Centene posted $53.6 billion in revenue, up 10% year over year, and $1.1 billion in profit in the quarter. That’s compared to a loss of $253 million the same time last year when Centene was caught off guard by higher spending — the insurer’s first quarterly loss in more than two years.
    • “Centene raised its 2026 financial outlook on Tuesday following the outperformance, which TD Cowen analyst Ryan Langston called “huge.”
    • “Any way you slice it, this was a fantastic quarter,” CFO Drew Asher said during a morning call with investors.”
    • “It’s the second beat-and-raise this year for the St. Louis-based insurer, following a buoyant first quarter when Centene bumped its 2026 guidance on the back of better controlled medical costs.” 
  • BioPharma Dive tells us,
    • “GSK is turning to a multibillion-dollar cost-cutting program to help the company grow profits while absorbing the impact of a sizable patent cliff.
    • “In its latest quarterly earnings report on Tuesday, the British pharmaceutical company revealed a three-year restructuring plandesigned to save a total of about £1.9 billion, or $2.5 billion, per year. GSK didn’t disclose specific details about the plan, but said that it should “simplify the organization” and help “reallocate capital and resources” towards specialty medicines.
  • MedTech Dive adds,
    • “Boston Scientific announced a global restructuring that will involve changes to its supply chain and organizational structure.
    • “The heart device company said in a Monday securities filing that it expects “some headcount reductions,” though it will still post new jobs in areas of growth. Boston Scientific did not say how many positions it expects to cut. The company did not respond to MedTech Dive’s request for comment by publishing time.
    • “In total, the company expects about $700 million to $800 million in pre-tax charges, according to the filing. The restructuring, approved by the company’s board, is expected to start this year and be complete by the end of 2029.”
  • Beckers Payer Issues informs us,
    • “Deferred elective surgery was a through-line of second-quarter earnings calls at four of the country’s largest for-profit hospital operators. But their executives do not agree on what is driving the slowdown, or whether it represents lost demand at all.
    • “Nashville, Tenn.-based HCA Healthcare, Franklin, Tenn.-based Community Health Systems and Dallas-based Tenet Healthcare all reported softness in elective volumes, particularly in high-acuity areas such as orthopedic and cardiac care that generate some of hospitals’ strongest margins. 
    • “King of Prussia, Pa.-based Universal Health Services reported milder surgical softness alongside a broader volume rebound and pinned the weakness on a different cause.
    • “The distinction matters because the competing explanations point to very different futures. If patients are postponing care they cannot afford, the volume loss reflects a demand problem that additional capital and capacity will not solve. If cases are shifting to lower-cost settings, the revenue has not disappeared; it has just moved somewhere else.”
  • Beckers Hospital Review points out,
    • “New Hampshire is the best state for healthcare while Alaska is the worst, according to an analysis published July 27 by WalletHub.
    • “The personal finance company compared the states and the District of Columbia across three dimensions: cost, access and outcomes. Analysts then evaluated the dimensions across 44 metrics, including average monthly insurance premiums, hospital beds per capita, emergency room wait times, infant mortality rates and the share of patients readmitted to hospitals. Each metric was graded on a 100-point scale, with 100 representing the best healthcare at the most reasonable cost. WalletHub then calculated each state’s weighted average across all metrics to produce an overall score and used the resulting scores to rank the states. 
    • “Iowa ranked first for cost, North Dakota ranked first for access and New Hampshire ranked first for outcomes.”
  • Beckers Clinical Leadership notes,
    • “Of the 679 U.S. hospitals designated as “Magnet” hospitals for nursing excellence, about 5% have earned the recognition more than six times. 
    • “The American Nurses Credentialing Center awards Magnet recognition to hospitals based on their quality of patient care and nursing excellence. As of July 28, 36 hospitals have received six or more Magnet designations — representing just 0.6% of the nation’s 6,100 hospitals. 
    • “Since Dec. 31, 2025, four hospitals have earned their sixth Magnet designation: Englewood (N.J.) Hospital, Hospital for Special Surgery in New York City, Penn Medicine Lancaster (Pa.) General Hospital and Houston Methodist Hospital.
    • [The article lists} the 36 hospitals that have received this honor six or more times.
  • Per Fierce Healthcare,
    • “LifeBridge Health’s Sinai Hospital of Baltimore is putting an artificial intelligence-powered diagnostic for sepsis into clinical use, bringing a research-backed tool to the patients’ bedside.
    • “Chicago-based Prenosis, a biology-based technology company, developed Sepsis ImmunoScore, an AI-powered tool that can spot the early signs of sepsis. The tool analyzes 22 parameters to identify patterns in a patient’s biological immune response, enabling clinicians to detect sepsis or its progression within 24 hours.
    • “Sepsis ImmunoScore received the U.S. Food and Drug Administration’s first authorization for software to diagnose sepsis in 2024. Prenosis’ solution was approved through the FDA’s De Novo pathway.”
  • and
    • “Virtual care and health navigation company Included Health inked a deal to acquire Firefly Health to scale health plan alternatives for employers.
    • “In January, Included Health launched an alternative health plan design for employers, broadening its existing all-in-one virtual care platform. Firefly Health, founded in 2017, is a primary care and health plan provider serving more than 20,000 individuals nationally. 
    • “The deal is expected to close in the third quarter of 2026. The companies did not disclose financial details of the acquisition.”

Monday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “As the Senate speeds toward its upcoming August recess, President Donald Trump is turning up the pressure on Senate Majority Leader John Thune to keep his chamber in session and in Washington instead. 
    • “So far, that’s unlikely.  “You could stay here till Christmas” and the situation wouldn’t change, Thune said. “If I thought there was a path to getting a result, I’m all for it.” 
    • “The president posted to Truth Social on Monday morning that “Thune should not allow the United States Senate to ‘leave town’ until it passes” the SAVE America Act, a GOP-crafted package that would require proof of citizenship to register to vote and photo ID at the polls.
    • “The sweeping bill does not have the 60 votes needed to advance through the Senate — a message the South Dakota Republican leader has reiterated both publicly and privately to the other end of Pennsylvania Avenue.” 
  • Per a U.S. Senate Committee news release,
    • “On Thursday, July 30, the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on bills to increase Americans’ educational opportunities and give them more tools to secure a strong retirement. The Committee will also vote the nominations for Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services, the Director of the Centers for Disease Control and Prevention, and the Secretary of the U.S. Department of Labor.”
  • Govexec relates,
    • “While lawmakers are debating what an appropriate regulatory framework for artificial intelligence should be, experts who spoke at a panel on Monday noted that federal employees have been using the technology for years to develop all sorts of regulations. 
    • “Cary Coglianese, a regulation professor at the University of Pennsylvania, said that agencies, for example, have been using AI to analyze thousands of public comments that some proposed rules receive. 
    • “Back in the day, contractors would literally photocopy comments, clip them out and sort them in different categories — and do what essentially natural language processing tools can do now so quickly and rather effectively,” he said. 
    • “But as the technology advances, speakers on the panel — which was sponsored by the Coalition for Sensible Safeguards, a left-leaning group of more than 220 regulatory-focused organizations — argued that AI could take over more steps in the rulemaking process, potentially supercharging the Trump administration’s efforts to slash regulations and downsize the federal government.”
  •  FEHBlog observation: The government can use AI for many more tasks, and you don’t have to be left leaning to be concerned about this development.
  • Fierce Healthcare tells us,
    • “A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.
    • “The Consumer Product Safety Commission, responsible for tracking and issuing recalls of dangerous products sold in the U.S., began discreetly pressuring hospital executives this year to share personally identifiable health data with a private contractor. But hospital lawyers and other industry experts have questioned the agency’s authority to collect, its ability to safeguard such a swath of sensitive information, and whether it has followed the legal process to overhaul its surveillance system.
    • “After KFF Health News asked the CPSC about the new system, the agency announced the program on July 21. Left unmentioned, however, is the alarm it has raised among hospital executives, as well as the nature and extent of the agency’s data demands.”
  • and
    • “A new analysis finds that Medicare Advantage enrollees spend less on average than those in the traditional program, but report similar satisfaction levels.
    • “ATI Advisory conducted the study on behalf of the Better Medicare Alliance, analyzing data from the Medicare Current Beneficiary Survey and Cost Supplement files from 2021 to 2023. The analysis found that MA enrollees spent $2,824, or 36%, less out-of-pocket on average in 2023 compared to those in fee-for-service Medicare.
    • “And the difference in spending has risen over time, with savings 16% higher in 2023 than in 2022, according to the report.
    • “Twelve percent of MA beneficiaries said they faced a significant cost burden, or spent more than 20% of their income on healthcare, compared to 24% of people enrolled in traditional Medicare.”
  • Beckers Payer Issues adds,
    • Medicare Advantage will account for 57% of overall Medicare enrollment by 2036, up from 51% this year, according to a July report from the Congressional Budget Office.
  • and
    • “Four more Medicare Advantage prescription drug plans have received five-star ratings thanks to CMS’ recalculation.” * * *
    • In a July 21 letter to MA organizations, CMS said ratings stayed the same for 61%, increased for 9% and declined for 30% of contracts. The agency did not change ratings for plans that had worse performance in the latest review. The threshold for MA plans earning additional payments is four out of five stars. Top plans get their own perks, though, such as special enrollment period privileges and further rebate benefits.
    • CMS clarified to Becker’s that it only updated overall ratings, not the separate Parts C and D summary ratings, on the plan finder.
    • Here are the four contracts joining the five-star club:
      • Renown Health
        • Hometown Health Plan (Senior Care Plus) — Contract H2960
      • Rifkin Managed Care Holding
        • Provider Partners Health Plan of Texas — Contract H4054
        • Provider Partners Health Plan of Pennsylvania — Contract H4093
      • Longevity Health Founders

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • Nearly 100 people in 17 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials said Friday.
    • The 98 people had illnesses that started between Nov. 21 and June 30, according to the FDA. No deaths have been reported, but 26 people have been hospitalized.
    • Investigators have determined that shell eggs recalled by Midwest Poultry Services are a likely source of the germ, but the Indiana-based company doesn’t account for all the illnesses.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
    • “Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
    • “SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
  • Fierce Pharma relates,
    • “The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
    • “Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note.
    • “Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants.”
  • Contemporary OB/GYN informs us,
    • “Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician’s order, the company noted in a July 24, 2026, news release.
    • “The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.
    • “BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.”
  • NBC News San Diego CA points out,
    • “The Food and Drug Administration has recalled a commonly prescribed thyroid medication.
    • “The recall involves levothyroxine sodium tablets that are used to treat hypothyroidism and decrease the size of enlarged thyroid glands, according to Mayo Clinic.
    • “The FDA said they had been functioning as “subpotent drugs,” meaning they had less of an active ingredient and were ultimately less effective.
    • “Major Pharmaceuticals packaged and distributed the recalled tablets, while Cardinal Health also distributed some of the recalled products.
    • “Twelve different dosages and cartons from the two companies were listed in the FDA’s recall notice. You can read the full list here.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S is asking a federal judge to halt Eli Lilly & Co.’s advertisements for its GLP-1 drugs, escalating a legal fight against the company’s campaign for weight loss treatments.
    • “The company said Friday [July 24] it filed a motion for preliminary injunction seeking to block Lilly’s advertisements of its obesity drugs, days after filing a lawsuit accusing the company of deceptive promotions. 
    • “Misleading advertisements that selectively compare lower doses of Novo Nordisk’s medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly’s drugs are vastly superior, and that is simply not true,” John F. Kuckelman, senior vice president and group general counsel of Novo, said in a statement.”
  • and
    • “Johnson & Johnson on Monday said it agreed to a $5.5 billion commitment to resolve litigation related to claims that its talc products caused ovarian cancer. 
    • “The drugmaker said the proposed resolution represents “an efficient conclusion” to the lawsuits. The agreement requires the participation of lead plaintiff firms in ovarian talc litigation pending in state and federal court that represent at least 95% of claims, according to J&J. 
    • “While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” J&J Vice President of Litigation Erik Haas said in the statement on the company’s website.” 
  • Beckers Payer Issues identifies five health system vs. payer lawsuits to watch.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “More than one-third of women and one-quarter of men engage in intentional outdoor tanning, with variance observed by age, race, physical activity level, and alcohol use, according to a study published online July 22 in JAMA Dermatology.
    • “Dawn M. Holman, M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the prevalence of intentional outdoor tanning among U.S. adults. The analysis included 31,615 adults participating in the 2024 National Health Interview Survey.” * * *
    • “These findings support the need to address intentional outdoor tanning in the context of skin cancer prevention,” the authors write. “The variation in demographic and behavioral factors points to venues for future research and interventions.”
  • The American Medical Association lets us know “what doctors want patients to know about summer skin safety” and “what doctors want patients to know about cardiac stress tests.“
  • The American Hospital Associagtion News relates,
    • “The Substance Abuse and Mental Health Services Administration July 27 released results from its latest national survey on drug use and mental health. The survey found that fewer adolescents 12-17 and adults 18-25 used alcohol, tobacco, marijuana and other drugs between 2021 and 2025. In addition, 27.6% of adolescents received mental health treatment in the past year, while 21.6% of adults 18 or older received treatment. The survey highlighted additional findings on suicide, substance use treatment and recovery.”
  • and
    • “The Association for the Advancement of Blood and Biotherapies Interorganizational Task Force on Domestic Disasters and Acts of Terrorism announced July 24 that the U.S. blood supply is at significant risk for shortages due to weeks of decline in blood donations. The task force said the reduced supply is more pronounced in certain areas of the country, and in some areas blood collectors are already reporting an impact on the availability of blood for some patients. The organization is urging eligible donors to make and keep an appointment to donate blood as soon as possible. An AHA Member Advisory will be issued on the matter, which will include a call to action and resources for conserving blood supplies.” 
  • MedPage tells us,
    • “Despite the availability of multivalent pneumococcal vaccines, infants remain susceptible to invasive pneumococcal diseases.
    • “In this French study, infants immunized against RSV with nirsevimab were about 35% less likely to be hospitalized for invasive pneumococcal disease through 9 months.
    • “The rise in pneumococcal disease cases in kids involving serotypes not covered by vaccines highlights the need for complementary prevention strategies, the researchers said.”
  • and
    • “Diabetes and weight loss are associated with an increased risk of fragility fractures, which can be associated with substantial morbidity and mortality.
    • “In this retrospective study of adults with type 2 diabetes, those starting a GLP-1 drug had a 21% lower risk of fragility fractures over 3 years compared with initiators of a DPP-4 inhibitor.
    • “The lower fracture risk associated with GLP-1 drugs was independent of changes in body mass index.”
  • Health Day adds,
    • “Worried that your Ozempic is becoming less effective over time?
    • “Don’t worry — you’re still eating less, even if you are feeling a bit hungrier, a new study says.
    • “People on semaglutide for weight loss continue to eat less even after they’ve taken the drug for more than a year, researchers report in the August issue of The American Journal of Clinical Nutrition.
    • “While some of the drug’s early reduction of hunger and food-related thoughts wanes over time, people continue to eat substantially fewer calories compared to others provided a placebo, researchers found.”
  • MedScape notes,
    • “A compression device worn around the abdomen during colonoscopy reduced cecal intubation time by more than 1.5 minutes and significantly lowered post-procedural pain, the need for manual abdominal pressure, and patient position changes. Greatest improvements were seen in patients who were lean or had obesity.”
  • Per a National Institutes of Health news release,
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. Researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” said senior author Michael Benatar, M.D., Ph.D., a professor of neurology and public health sciences at the University of Miami. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Payer Issue tells us eight things to know about healthcare spending trends. 
  • Modern Healthcare reports,
    • “Cone Health CEO Dr. Paul Krakovitz said the system is focusing on value-based care coordination.
    • “Cone’s parent system, Risant Health [,a subsidiary of Kaiser Permanente], provides a national network with added scale and expertise to operate in a highly competitive healthcare market.
    • “Krokovitz said the system is expanding to take advantage of North Carolina’s booming population growth.” * * *
    • “We’re coming up on our second anniversary soon. The tools that Risant is bringing us in terms of value-based care and giving us national scale have been impressive. They’ve been very open-minded. Most importantly, they’ve stuck to the value of the deal, which has been making sure Cone Health remains a community-based health system.”
  • Beckers Hospital Review relates,
    • “King of Prussia, Pa.-based Universal Health Services recorded an operating income of $516.7 million (11.1% operating margin) during the second quarter of 2026, compared to an operating income of $500.3 million (11.7% margin) during the same period last year, according to its July 27 financial report.” * * *
    • “UHS operates 30 inpatient acute care hospitals, 346 inpatient behavioral health facilities, about 170 outpatient and other facilities, a health plan and a physician network in 40 states, Washington, D.C., Puerto Rico and the United Kingdom.”
  • Leapfrog posted its 2026 hospital safety ratings.
  • The Wall Street Journal informs us,
    • “Argenx agreed to buy Forte Biosciences for $2.2 billion to strengthen its immunology pipeline.
    • “The purchase price of $77 a share in cash represents a 41% premium to Forte’s closing price on Friday.
    • “The deal adds Forte’s experimental drug FB102, which Argenx said has potential to address multiple autoimmune diseases.”
  • and
    • “AstraZeneca reported higher second-quarter sales driven by cancer medicines and said it remains on track to hit its 2030 revenue target.
    • “AstraZeneca’s second-quarter revenue rose to $15.38 billion from $14.46 billion, driven by a 15% increase in oncology product sales.
    • “Chief Executive Pascal Soriot sought to reassure investors after a recent trial failure raised doubts about the company’s 2030 revenue goal.”
  • MedCity News discusses “What Happens When Patients Trust AI Over Their Doctor?”
    • As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.